Olympus Corporation of the Americas

Role Description The Director, BD Regulatory Affairs is responsible for strategic and tactical functional support for business development projects. This important role will be a key partner to the global BD team, ensuring that the function’s perspective is embedded in diligence and integration efforts. Job Duties - Serve as the global liaison between RA and the BD team. - Responsible for providing in-depth analysis of Medical Device/Healthcare quality management system functionality and maintenance to contribute to transfer of business activities. - Provide strategic guidance on global regulatory pathways and market access planning. - Accountable for developing, maintaining, and executing a RA M&A readiness plan. - Assess current capabilities, systems, policies, processes, organizational structure, and resources for conducting RA due diligence, integration strategy/planning activities, and integration execution against best practices. - Create the tools and standard operating processes necessary to support RA efforts throughout the full business development cycle (pre deal through integration), including ownership of assigned deliverables. - Develop a clear implementation plan, agreed to by BD and RA senior leaders. - Maintain an up-to-date view of all projects in the business development pipeline. - Plan for functional support by estimating timing and resource requirements per project. - Communicate and coordinate needs within the function to identify and obtain adequate support at global and regional levels. - Ensure the appropriate global regulatory requirements are considered as part of due diligence and appropriately incorporated into integration activities. - Accountable for ensuring all regulatory documentation is maintained, well-organized and ready to be audited by global regulatory authorities / notified bodies. - Develop an understanding of business unit strategies and product portfolios. - Provide Business Unit Leaders and other key stakeholders regulatory guidance strategy to assist in BD decision making, integration strategy/planning, and execution. - Build and maintain a network of resources in all regions, across all businesses and divisions. - Coordinate with global and regional RA teams to ensure efforts are aligned, obtain approvals, and assign resources. - Take responsibility for all RA aspects of each business development project by: - Conducting or overseeing due diligence and integration activities. - Building a functional plan for each project to ensure that functional risks are identified, and actions are planned. - Securing necessary approvals from RA/regional leadership for due diligence reports and integration strategy/plans. - Stay current on industry and functional trends by reviewing the output of relevant regulatory intelligence reports and apply learning to target evaluation and integration. - Develop personal expertise and train RA personnel on BD tools & processes. - Coach colleagues on how to effectively participate in due diligence and integration planning and execution. Qualifications - Bachelor’s degree in a science-related discipline; Masters preferred. - Minimum of 15 years of directly related Regulatory Affairs experience; preferably at least 10 years in a global role. - Experience with global submissions and determining regulatory pathways. - Knowledge of and experience managing a Quality Management System and leading external QMS certification/surveillance audits. - Thorough understanding of global submission requirements and appropriate design control requirements in order to satisfy global Health Authority submission standards. - In-depth knowledge of global quality and regulatory requirements for the development of new product and maintenance support for sustaining market access. - Experience in Business Development/M&A projects. - Demonstrated ability to work cross-functionally. - Demonstrated ability to lead programs/projects. - Has sense of passion, drive and perseverance to accomplish goals. - Excellent team player. - Global understanding of product domains and key technology/therapeutic area/R&D disciplines. - Excellent leadership and interpersonal skills, including the ability to work across cultures and personality types. - High business acumen: ability to learn quickly and adapt to new circumstances; comfort and ability to effectively order the unknown; intellectual agility. - Excellent communication skills, both verbal and written; ability to quickly distill complex information into actions/recommendations. - Excellent ability to read and influence senior decision makers bridging organizational complexities. - Strong project management skills, including planning, budgeting, and resource management. - Excellent understanding of the typical functional roles and responsibilities in R&D. - Practical understanding of global regulatory/quality standards and requirements. - Potential for travel up to 20% (deal-needs dependent); domestic and international. Benefits - Competitive salaries, annual bonus and 401(k) with company match. - Comprehensive medical, dental, vision coverage effective on start date. - 24/7 Employee Assistance Program. - Free live and on-demand Wellbeing Programs. - Generous Paid Vacation and Sick Time. - Paid Parental Leave and Adoption Assistance. - 12 Paid Holidays. - On-Site Child Daycare, Café, Fitness Center. - Work-life integrated culture that supports an employee centric mindset. - Offers onsite, hybrid and field work environments. - Paid volunteering and charitable donation/match programs. - Employee Resource Groups. - Dedicated Training Resources and Learning & Development Programs. - Paid Educational Assistance.

Role Description This role will serve as the principal global strategic architect and operational leader for the Advanced Endoluminal Robotics GI portfolio. Operating primarily as a senior executive for the Endoscopic Solutions Division (ESD), this role ensures a unified global approach to the digital and robotic surgery markets across divisions. The successful candidate will drive the global strategy, development, and commercialization of our next-generation robotic platforms for GI and bridge early-stage technical innovation, clinical trial validation, and complex capital/consumable business models to maximize market adoption and sustain long-term competitive advantages. This position will report in to the head of AEI solutions (senior advisor) and will be the primary strategic partner for both the short and long-term strategic plan. Job Duties - Strategic Leadership & Corporate Governance - Portfolio Architecture: Formulate, refine, and own the 3-to-5-year global strategic roadmap for the Endoluminal Robotics portfolio, balancing capital system placement with consumable pull-through. - Executive Liaison: Serve as the primary strategic advisor executing directives from the Steering Committee, presenting high-stakes business cases directly to the Global Executive Team. - Matrix Synergy: Direct, align, and streamline cross-functional operations, removing organizational friction and ensuring unified commercial execution. - Inorganic Growth (M&A): Partner closely with Corporate Business Development to identify, evaluate, and conduct commercial due diligence on target acquisitions, licensing deals, and strategic partnerships. - Digital: Support the development of strategies for digital health integration, cloud connectivity, data privacy compliance, and AI-driven clinical decision support tools. - Innovation & In-Market Transformation - Upstream Marketing Leadership: Guide cross-functional project teams (R&D, Clinical Affairs, Regulatory) through the front-end innovation process, defining unmet user needs for future robotic generations. - Drive Commercialization: Develop global go-to-market strategies for new robotic systems. - Agile Market Testing: Fund, launch, and measure rapid, small-scale commercial pilots in target global areas to stress-test ecosystem economics prior to full-scale launches. - Value Proposition Design: Translate intricate technological and engineering performance metrics into crystal-clear clinical, financial, and operational value messaging for hospital C-suites and Key Opinion Leaders (KOLs). - HEOR: Collaborating with Medical Affairs to build a robust health economics and outcomes research (HEOR) strategy to justify premium robotic pricing to hospital economic buyers. - Market Intelligence & Investors Alignment - Predictive Market Modeling: Design global primary and secondary research frameworks to track competitor placements, regulatory shifts, and regional pricing pressures. - KOL Engagement: Cultivate relationships with world-class endoscopists and surgeons. - Market Intelligence: Monitor competitive landscapes, intellectual property, and emerging surgical trends. - Investor Relations Advisory: Support Corporate Planning and Investor Relations by supplying strategic insights that clearly articulate the company’s digital/robotic runway, valuation, and intellectual property (IP) strength to the investment community. Qualifications - MBA, Master’s, or PhD in Engineering, Biomedical Sciences, Healthcare Management, or an equivalent business-focused discipline. - Minimum of 10 years of progressive commercial strategy, product management, corporate development, or business transformation leadership within the medical device industry. - Domain Expertise: Ideally direct experience operating within Surgical Robotics, Digital Surgery Ecosystems, or Advanced Interventional Endoscopy. - Track Record: Proven experience in leading Capital/Disposable medical ecosystems to global success. - Regulatory Acuity: Strong understanding of FDA (PMA/510k) and CE Mark frameworks. - Agility: Experience navigating rapid technological shifts and AI integration in surgery. - Matrix Mastery: Proven ability to influence, persuade, and gain buy-in across decentralized, multi-divisional corporate environments without direct line-reporting authority. - Financial & Economic Acuity: Advanced capability in building discounted cash flow (DCF) models, total cost of ownership (TCO) calculators, and capital-to-disposable monetization strategies. - Communication: Skillful at translating complex engineering data into clinical value propositions. - Clinical & Technical Fluency: Comfort collaborating equally with GI endoscopists, clinical trial investigators, regulatory affairs consultants, software/AI engineers, and financial analysts. - Travel ~ 35% (domestic and international). Benefits - Competitive salaries, annual bonus and 401(k)* with company match. - Comprehensive medical, dental, vision coverage effective on start date. - 24/7 Employee Assistance Program. - Free live and on-demand Wellbeing Programs. - Generous Paid Vacation and Sick Time. - Paid Parental Leave and Adoption Assistance*. - 12 Paid Holidays. - On-Site Child Daycare, Café, Fitness Center**.

Role Description The Project Manager is responsible for the successful delivery of tech-enabled change projects within the organization, managing and coordinating the full project lifecycle from initial analysis and requirement capture to deployment and transition into business-as-usual. The Project Manager is responsible for delivering an agreed scope on time and within budget, through driving value-based outcomes and managing risks, assumptions, issues, and dependencies. The Project Manager will work with delivery teams (may include 3rd parties) and keep sponsors updated through robust governance and regular reporting. “The job is conducted in line with our Core Values which are: agility, empathy, long-term view, unity and integrity. Olympus is an equal opportunities employer championing a culture of equality, diversity and inclusion embedded throughout the organization and workforce.” Job Duties - Project Management - Deliver an agreed technology scope on time and within budget. - Drive value-based outcomes through the full project lifecycle from initial analysis to post-deployment. - Own (create and maintain) the project plan of key activities, outputs, and dependencies. - Own the project financials (forecasting, budgeting) and resource model. - Identify and onboard resources required to deliver the project scope, oversee and coordinate day to day team activities aligned to the project plan. - Project Governance and Communications - Track and mitigate risks and issues, document and manage assumptions and dependencies, escalating where required. - Effectively manage relationships with delivery teams, including 3rd parties where required. - Manage expectations of sponsors and other stakeholders through timely, well-structured communications on progress and project health. - Drive robust project governance, taking into consideration delivery, architecture, and change management requirements. - Establish the regular meeting cadence required to effectively manage and govern project delivery. - Program/Project Management Community - Actively participate in a program/project management community to share good practice and lessons learnt from a global and regional perspective as well as to hone skills and master core capabilities. - Provide input and support to establish good practice project guidelines and a clear project framework to be adhered to by all programs and projects; continuously update with good practices. - People Management - Lead, motivate, develop, and appraise team members so that their individual and collective performance is of the required standard and meets the current and future needs of the business. - Other responsibilities / duties as assigned. Qualifications - Bachelor’s degree or higher in IT, Computer Science or Business Management (or equivalent and related experience preferred). - Minimum of 3-5 years of working experience as a Project Manager in the IT sector. - Proven track record of successfully driving and delivering end-to-end large complex scaled IT solutions/projects or system implementations projects. - Solid technical background, with understanding or hands-on experience in software and system development. - Experience of negotiation and working with project and process management. - Experience in stakeholder management. - Experience working with Microsoft Office suite (Project, Word, Excel). - Good planning and organization skills with key attention to budget and resource management. - Demonstrable problem-solving skills. - Demonstrable organizational skills. Requirements - Project Management qualifications desirable e.g., PMP/ Prince II certifications or equivalent. Benefits - Competitive salaries, annual bonus and 401(k)* with company match. - Comprehensive medical, dental, vision coverage effective on start date. - 24/7 Employee Assistance Program. - Free live and on-demand Wellbeing Programs. - Generous Paid Vacation and Sick Time. - Paid Parental Leave and Adoption Assistance*. - 12 Paid Holidays. - On-Site Child Daycare, Café, Fitness Center**.

Role Description As a Medical Safety Specialist II (MSSII) you will have an integral role in the day-to-day functioning of the global medical safety organization. In this vital role, you will execute upon medical safety processes globally at Olympus. As an individual contributor you will influence the science and practice of all medical safety activities related to the detection, assessment, understanding of product risks and their effective mitigations to protect patients worldwide. You will demonstrate the ability to apply your solid clinical experience, product expertise, and medical safety domain knowledge to collaborate and influence patient safety in activities being performed cross-functionally across the product lifecycle for all Olympus therapeutic areas. You will report directly to the Medical Safety Director as a member of the global medical safety team. You must be adept at cultivating strong collaborative relationships across: - Medical & Scientific Affairs - Infection Prevention & Control - Quality Affairs & Regulatory Affairs - Research & Development - Legal - Health Care Compliance Job Duties - Complaint Assessment: Uses tools created for consistency and SOPs to medically assess causality and severity of adverse events reported to Olympus. Provides recommendations for escalation. - Risk Management: Develops expertise of the risk management file documents for assigned products with responsibility to provide information related to observed and potential patient harm, severity, and mitigations to reduce potential for harm. - QARA Processes: Develops an understanding of medical safety's role in QARA processes across the product life cycle and provides Medical Safety review and approval for PMS documentation, labeling/IFU creation, Clinical Evaluation Reports, developing responses to inquiries from regulators, Human Factors Engineering reports, non-conformance dispositions, and CAPA. - Cross-functional meetings: Uses Medical subject matter expertise to represent Medical Safety in cross-functional meetings related to HHA, FCA, trending, and complaint review boards; internally aligns on and contributes to escalation of key events or issues with potential for safety impact. Engages more experienced team members if additional data or information is needed to facilitate medically sound decisions related to patient safety. - Medical Safety or cross-functional projects: Plays an active role in contributing to Medical Safety priorities and initiatives, aligning goals and performance with business and functional objectives. - Uses clinical knowledge and experience to serve as a medical safety expert contributor to assess and understand product risk and influence and advise on mitigation strategies. - Searches, reviews, trends, understands, and interprets adverse event data, literature, and other safety-relevant data for the purpose of signal detection. - Demonstrates knowledge and experience working with: - Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820) - Various standards (GCP, ISO 13485, ISO 14971) - Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs) - Corrective Actions – Preventative Actions (CAPAs) - Health Hazard Assessment & Field Corrective Actions - Resolving product non-conformances - IMDRF dictionary terms and proficiency in adverse event coding and reporting - Post market surveillance, escalations, and mandatory safety reporting requirements - Endoscopic diagnostic and therapeutic procedures in the following therapeutic areas: Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection Prevention and Control - Maintains knowledge of Olympus standard operating procedures, guidance, work instructions, training, and competencies. - Demonstrates strong self-motivation and individual leadership skills, including the ability to communicate and influence multi-departmental, cross-functional teams and contribute to the resolution of quality-related issues in a timely and effective manner. - Demonstrates experience staying engaged with worldwide clinical practice guidelines, safety requirements, and global Competent Authority regulations. Qualifications - BS/BA Degreed Health Care Professional required. - Minimum of 4 years of experience working as a Health Care Professional (RN). DNP, PA-C preferred. Direct patient care experience is required (Hospital, Medical or Clinical Practice, with a preference for clinical experience in the areas of Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection prevention and control). - Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience (Medical Device preferred to Pharma) OR Progressive leadership experience in the health care setting. Medical Safety (Medical Device preferred to Pharma) or Risk Management (Medical Device) experience. - Extended periods of time doing computer-based work. - Extended hours to accommodate international / intercontinental global time schedules. - While performing the duties of this job, the employee is regularly required to be independently mobile. - The employee is also required to interact in-person and virtually with peers and co-workers. - Travel up to 10% may be required. Benefits - Competitive salaries, annual bonus and 401(k)* with company match - Comprehensive medical, dental, vision coverage effective on start date - 24/7 Employee Assistance Program - Free live and on-demand Wellbeing Programs - Generous Paid Vacation and Sick Time - Paid Parental Leave and Adoption Assistance* - 12 Paid Holidays - On-Site Child Daycare, Café, Fitness Center** Company Description For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: - Patient Focus - Integrity - Innovation - Impact - Empathy

Role Description The Principal Quality Engineer is the primary point of contact for all product quality matters across the product lifecycle. This role provides end-to-end product quality leadership, ensuring compliance with regulatory requirements and internal standards while driving continuous improvement. The individual partners cross-functionally with R&D, Manufacturing, Regulatory, Supply Chain, and Post-Market teams to proactively identify, assess, and resolve product quality issues. Job Duties - Product Quality Leadership - Serve as the division’s key partner and subject matter expert for end-to-end product quality. - Act as the primary escalation point for product quality issues, metrics, and risk management activities. - Provide Product QA leadership for all AIRs (Adverse Incident Reports), HHA/FCAs (Health Hazard Assessments/Field Corrective Actions), and product escalations, determining potential cross-product or systemic impact. - Ensure alignment with regulatory requirements including 21 CFR Part 820, ISO 13485, and applicable global regulations. - Corrective and Preventive Action (CAPA) - Determine and implement robust corrective and preventive actions to address product and process deficiencies. - Lead structured, formal problem-solving teams (e.g., 8D, DMAIC, root cause analysis) to resolve significant customer, product, and supplier complaints. - Oversee CAPA effectiveness checks and ensure sustainable systemic improvements. - Nonconformance & MRB Support - Support and provide leadership to the Materials Review Board (MRB) in investigation and disposition of nonconforming materials (NCRs). - Drive timely resolution of product quality issues through cross-functional collaboration. - Risk Management & Process Controls - Facilitate and support cross-functional execution of: - Process Flowcharts - PFMEAs - Control Plans - Procedures and Work Instructions - Inspection Data Sheets - Lead implementation and continuous improvement of quality systems, assurances, and process controls designed to meet or exceed internal and external requirements. - Utilize strong data analysis and trending skills to identify emerging risks, assess failure modes, and recommend mitigation strategies. Qualifications - Bachelor’s degree in Engineering or related technical field required. - 10+ years of product quality experience in the medical device industry or other regulated environment. - Demonstrated experience with design transfer, process validation, CAPA systems, and complaint investigations. - Experience leading cross-functional problem-solving teams. - Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and risk management principles (ISO 14971). - Strong analytical and statistical data analysis capabilities. - Excellent root cause investigation and structured problem-solving skills. - Proven leadership and cross-functional collaboration abilities. - Strong written and verbal communication skills. - Ability to influence without direct authority and manage multiple priorities in a dynamic environment. - Must be available for regional and international travel. Preferred - Advanced degree preferred. Benefits - Competitive salaries, annual bonus and 401(k)* with company match - Comprehensive medical, dental, vision coverage effective on start date - 24/7 Employee Assistance Program - Free live and on-demand Wellbeing Programs - Generous Paid Vacation and Sick Time - Paid Parental Leave and Adoption Assistance* - 12 Paid Holidays - On-Site Child Daycare, Café, Fitness Center**

Role Description As a Principal Medical Safety Specialist (Pr. MSS) you will have an integral role in the day-to-day functioning of the global medical safety organization. In this vital role you will execute upon Olympus medical safety processes globally. As an individual contributor, you will lead and influence the science and practice of all medical safety activities related to the detection, assessment, understanding of product risks and their effective mitigations to protect patients worldwide. You will demonstrate the advanced ability to apply your solid clinical experience, product expertise, and medical safety domain knowledge to lead, collaborate, and influence patient safety in activities being performed cross-functionally across the product lifecycle for all Olympus therapeutic areas. You will bring industry experience and expertise in the fundamentals of Medical Safety practices and processes to Olympus and will report directly to the Medical Safety Director as a member of the global medical safety team. Additionally, you will be expected to mentor and train other Medical Safety professionals and will use your expertise to contribute to the definition and formalization of medical safety engagement criteria in processes throughout the Olympus product lifecycle. You must be adept at cultivating strong collaborative relationships across: - Medical & Scientific Affairs - Infection Prevention & Control - Quality Affairs & Regulatory Affairs - Research & Development - Legal - Health Care Compliance Job Duties - Complaint Assessment: Contribute to the creation of tools and SOPs to be used by the medical safety team to medically assess causality and severity of adverse events reported to Olympus. Independently recommends escalation of key events. - Risk Management: Uses prior risk management experience to contribute to the development of pre/post market risk assessments and risk management file documentation, specifically providing information related to observed and potential patient harm, severity, and mitigations to reduce the potential for harm. - QARA Processes: Uses prior Medical Safety experience to contribute to the optimization of medical safety's role in QARA processes across the product life cycle by participating in activities to formalize and optimize the MS role. Additionally, provides Medical Safety review and approval for PMS documentation, labeling/IFU creation, Clinical Evaluation Reports, developing responses to inquiries from regulators, Human Factors Engineering reports, non-conformance dispositions, and CAPA. - Cross-functional meetings: Independently uses medical subject matter expertise to represent Medical Safety in cross-functional meetings related to HHA, FCA, trending, and complaint review boards; independently recognizes and contributes to escalation of key events or issues with potential for safety impact. Identifies data or information needed to facilitate medically sound decision making related to patient safety. - Medical Safety or Cross-functional projects: Plays an active role in driving and contributing to Medical Safety priorities and initiatives, aligning goals and performance with business and functional objectives. Will often lead initiatives and internally communicate progress on assigned initiatives. - Use your advanced clinical knowledge and medical safety experience to serve as a medical safety expert contributor to assess and understand product risk and influence and advise on mitigation strategies. - Search, review, trend, understand, and interpret adverse event data, literature, and other safety-relevant data for the purpose of signal detection. Qualifications - BS/BA Degreed Health Care Professional Required - 5+ years of experience working as a Health Care Professional (RN). - Direct patient care experience is required (Hospital, Medical or Clinical Practice, with a preference for clinical experience in the areas of Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection prevention and control) - 4+ years Medical Safety or Risk Management Experience (Medical Device preferred to Pharma) - Extended periods of time doing computer-based work - Extended hours to accommodate international / intercontinental global time schedules. - While performing the duties of this job, the employee is regularly required to be independently mobile. - The employee is also required to interact in-person and virtually with peers and co-workers. - Travel up to 10% may be required. - Ability to lead with influence without authority. - Personal integrity, ethics, and honesty - Excellent written and spoken English. - Ability to successfully influence and collaborate cross-culturally. - Fluency with medical terminology and proficiency in medical writing - Results oriented mindset. - Demonstrated attention to detail. - Strong problem-solving and excellent organizational skills - Ability to prioritize rapidly. - Aptitude to make decisions and execute directives. - Demonstrated proficiency with common MS Office programs (Word, Excel, PowerPoint, Teams) - Ability to listen and think critically (sometimes creatively) - Proficiency in public speaking and delivering presentations. - Experience working in a matrix management structure. - Excellent decision making/analysis skills; ability to manage multiple projects simultaneously. - Ability to be an initiative-taker and work independently to achieve on time deliverables. - Maturity to consistently balance a sense of urgency with diplomacy & empathy. - A keen sense of intuition to anticipate problems before they occur. - Wherewithal to work under tight deadlines, demonstrating initiative and flexibility. - Effective people skills that allow cultivation of working relationships that may or may not be part of direct team (cross functional environment). Benefits - Competitive salaries, annual bonus and 401(k) with company match - Comprehensive medical, dental, vision coverage effective on start date - 24/7 Employee Assistance Program - Free live and on-demand Wellbeing Programs - Generous Paid Vacation and Sick Time - Paid Parental Leave and Adoption Assistance - 12 Paid Holidays - On-Site Child Daycare, Café, Fitness Center

Role Description This is a global leadership role responsible for developing, leading, and continuously improving the company’s corporate and internal audit programs across all manufacturing, distribution, R&D, and support sites worldwide. This role ensures ongoing compliance with applicable global regulatory requirements, internal Quality Management System (QMS) standards, and industry best practices within the medical device industry. This role will lead global transformational change for Olympus Corporate Compliance. This position leads a team of corporate audit professionals responsible for: - Assessing site readiness - Identifying compliance risks - Driving sustainable corrective and preventive actions (CAPAs) - Promoting a culture of quality and continuous improvement The role serves as a strategic partner to Quality, Regulatory Affairs, Operations, and executive leadership to ensure inspection readiness and compliance excellence across the enterprise. Qualifications - Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field required; advanced degree preferred. - Minimum of 12 years of progressive experience required in Quality Assurance, Regulatory Compliance, or Quality Systems within the medical device or regulated healthcare industry. - Significant experience required leading global quality audit or internal inspection programs in a multinational organization. - Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR/IVDR, MDSAP, and other international regulatory frameworks. - Demonstrated experience interacting with regulatory agencies and supporting external inspections. - Proven leadership experience managing global teams and influencing senior stakeholders across complex organizations. - Certified Lead Auditor or equivalent quality certification (ASQ CQA, CQE, or similar). - Experience supporting remediation programs, compliance transformations, or quality system harmonization initiatives. - Strong analytical, communication, organizational, and problem-solving skills. - Familiarity with digital quality systems, audit analytics, and risk management methodologies. - Ability to travel domestic and internationally as required based on business needs. Requirements - Lead and oversee the global corporate audit program across all company sites and critical business functions. - Own, develop, deploy and continuously improve the corporate and internal audit quality system process. - Establish and maintain risk-based corporate and internal audit strategies aligned with applicable global regulations and standards. - Direct planning, execution, reporting, and follow-up activities for corporate and internal quality audits. - Evaluate site compliance to internal QMS requirements, regulatory expectations, corporate procedures, and industry standards. - Drive enterprise-wide compliance transformation and inspection readiness. - Partner with site leadership and functional stakeholders to address identified gaps, implement effective CAPAs, and strengthen quality system maturity. - Monitor and analyze inspection trends, systemic issues, and quality metrics to proactively identify compliance risks and opportunities for improvement. - Provide strategic guidance and subject matter expertise during regulatory agency inspections and external audits. - Develop standardized audit methodologies, tools, training programs, and governance processes to ensure consistency and effectiveness globally. - Build and lead a high-performing global team of internal inspectors and audit professionals. - Prepare and present corporate audit outcomes, compliance trends, and risk assessments to executive leadership and quality governance forums. - Maintain awareness of evolving global regulatory requirements and industry expectations. Benefits - Competitive salaries, annual bonus and 401(k) with company match - Comprehensive medical, dental, vision coverage effective on start date - 24/7 Employee Assistance Program - Free live and on-demand Wellbeing Programs - Generous Paid Vacation and Sick Time - Paid Parental Leave and Adoption Assistance - 12 Paid Holidays - On-Site Child Daycare, Café, Fitness Center - Work-life integrated culture that supports an employee centric mindset - Offers onsite, hybrid and field work environments - Paid volunteering and charitable donation/match programs - Employee Resource Groups - Dedicated Training Resources and Learning & Development Programs - Paid Educational Assistance

Role Description This role focuses on Product Quality and drives Patient Focus by leveraging problem-solving expertise and leadership acumen to accelerate product quality improvement, resolve issues, and ensure patient safety and customer satisfaction. Job Duties - Train, coach, and support CAPA Site Leads in the application of technical and analytical methods that accelerate CAPA closure and effectiveness. - Provide coaching for CAPA owners to drive the development of sound problem-solving and technical design review habits and techniques across Olympus. - Support the use of quality problem-solving tools such as Root Cause Analysis, 5 Whys, Ishikawa, etc. - Deploy and oversee a Design Assurance Quality Engineer training and development syllabus supporting the development of a patient-focused Quality Mindset and technical rigor across the Design Quality Assurance function. - Leverage extensive technical experience to support high visibility new product development, sustaining engineering, and CAPA efforts as assigned by Management. - Support high-priority complaint investigations, signal detection, and product issue escalations. - Other Quality Assurance responsibilities as assigned by Management. Qualifications - BS degree or equivalent in an engineering or life science discipline. - Minimum of 8 years’ experience working in an FDA regulated environment. - Demonstrated ability to manage and complete multiple projects and objectives and lead cross-functional teams. - Proficient with DMAIC/ Lean Six Sigma /Black Belt tools to analyze, drive root cause, and solve difficult problems. - Proficient with statistics, sampling strategies, quality systems trending, and process capability. - Proficient with Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDAQSRs, ISO 13485, ISO 14971. - Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities. - Strong track record of leading and influencing without direct authority across functional groups, leadership levels, and regions globally. - Excellent interpersonal, communication (written and oral), presentation, and facilitation skills. - Demonstrated ability to coach and mentor others. - Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio). - Demonstrates the highest ethical standards and actively promotes trust, respect, and integrity in all dealings both inside and outside the Company. - Six Sigma Green Belt Certification required. - Ability to travel up to 20% of time domestically and internationally. Requirements - Minimum of 3 years’ experience working in Medical Device or Pharma (preferred). - Six Sigma Black Belt is preferred. Benefits - Competitive salaries, annual bonus, and 401(k) with company match. - Comprehensive medical, dental, vision coverage effective on start date. - 24/7 Employee Assistance Program. - Free live and on-demand Wellbeing Programs. - Generous Paid Vacation and Sick Time. - Paid Parental Leave and Adoption Assistance. - 12 Paid Holidays. - On-Site Child Daycare, Café, Fitness Center. - Work-life integrated culture that supports an employee-centric mindset. - Offers onsite, hybrid, and field work environments. - Paid volunteering and charitable donation/match programs. - Employee Resource Groups. - Dedicated Training Resources and Learning & Development Programs. - Paid Educational Assistance.

Role Description Quality leader providing strategy, execution, oversight, training and mentoring to the organization for new product development, sustaining/lifecycle engineering, risk management and end to end product quality. Directly responsible for the Sustaining Design Assurance Organization in Hachioji (Ishikawa) Japan, with potential indirect reports in Hyderabad, India as deemed appropriate based on business needs. This includes Product Development Quality Engineering, Risk Management, and CAPA engineers. Job Duties - Mentors and leads the Hachioji, Japan Sustaining Design Assurance Engineering staff supporting new product development and sustaining engineering projects across GI, GI-ET, and GI-EUS products. - Champion and subject matter expert for customer and patient focused end to end Risk Management. - Supports all aspects of the product lifecycle for products in scope, including sustaining activities, design change management, complaint investigations and ongoing risk management activities/post market surveillance. - Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) and acts as a subject matter expert to demonstrate compliance to regulatory requirements and the Olympus Quality System. - Stakeholder and collaborator with senior management relating to project, process, business, and quality decisions. - Supports EUMDR and other state of the art regulatory standard requirements. - Support for Hachioji quality records, including but not limited to CAPAs, Nonconformances, post market risk assessments, HHA, and relevant internal and external audit findings. - Other Quality responsibilities, delegations and special projects as assigned by Management. Qualifications - BS degree or equivalent in engineering or life science discipline. - Minimum of 10-15 years of professional experience or equivalent training or equivalent training/education in quality or other engineering discipline. - Minimum of 5 years working in medical device new product development management position(s) and people leadership. - Proven track record in the global execution of New Product Development delivering on robust, customer and patient focused product quality, Concept through Post-Launch for WW markets. - Strong technical skills related to Design Assurance including VOC translation to Design Inputs and Outputs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics. - Ability to drive value and product differentiation through the Design Assurance Team. - Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the MedTech industry e.g., ISO, QSR, GMP, GLP, GCP, HIPAA, Design Controls, Human Factors, Risk Management practices. - Strong working knowledge of technical problem-solving skills. - Strong collaboration and influencing skills and the ability to work across functions. - Must be a change agent, highly and effectively organized, be a flexible self‑starter, team-oriented and excellent at prioritization and multitasking. - Strong track record of product and process continuous improvement is required. - A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect, and integrity in all dealings both inside and outside Olympus. - Focused, target driven with a positive attitude and a desire to improve patient and customer experience as well as company performance. - Up to 10% domestic travel. Requirements - MBA or other advanced degree strongly preferred. - Design or Process Black Belt is a plus. - Strong working knowledge of six sigma methodologies is a plus. Benefits - Competitive salaries, annual bonus and 401(k)* with company match - Comprehensive medical, dental, vision coverage effective on start date - 24/7 Employee Assistance Program - Free live and on-demand Wellbeing Programs - Generous Paid Vacation and Sick Time - Paid Parental Leave and Adoption Assistance* - 12 Paid Holidays - On-Site Child Daycare, Café, Fitness Center**

Role Description Olympus is seeking a dynamic and experienced Director of Program Management to join our Product organization. This role is pivotal in ensuring the successful delivery of complex, multi-disciplinary projects that drive our mission forward while continually improving our processes. As a key member of our leadership team, you will be responsible for orchestrating the seamless execution of product initiatives, fostering a culture of collaboration, and driving excellence in program management practices. This includes operating within and managing deliverables according to our Quality Management System (QMS) to ensure the highest quality products for our customers. This role is a highly cross-functional player/coach which will shape the future Program Management department for the Digital Health organization. Job Duties - Program Leadership: Lead and manage large-scale, cross-functional programs from concept through delivery, ensuring alignment with strategic objectives and business goals. - Strategic Planning: Collaborate with product management, engineering, and other stakeholders to define program scope, objectives, and success criteria. Develop and maintain comprehensive program plans, including schedules, resource allocation, and risk management strategies. - Stakeholder Management: Act as the primary point of contact for program-related communications, ensuring transparency and alignment among all stakeholders, including senior leadership, product teams, and external partners. - Execution Excellence: Drive program execution with a focus on delivering high-quality products on time and within budget. Implement best practices in program management, including Agile methodologies, to optimize efficiency and effectiveness. - QMS Compliance: Ensure all program deliverables adhere to the company’s Quality Management System (QMS) requirements. Oversee documentation, validation, and verification processes to maintain compliance with regulatory standards. - Quality Assurance: Collaborate with the Quality Assurance team to integrate quality checks and balances throughout the product development lifecycle. Facilitate audits and inspections to ensure ongoing compliance with industry standards and regulations. - Team Empowerment: Foster an environment where teams are empowered to make decisions and take ownership of their work. Promote a culture of continuous improvement, collaboration, and innovation. - Risk Management: Proactively identify and mitigate risks that could impact program success. Develop contingency plans and communicate effectively to ensure risks are managed appropriately. - Performance Metrics: Establish and track key performance indicators (KPIs) to measure program success and drive data-informed decision-making. Provide regular status updates and performance reports to leadership. - Coach and Development: Coach and develop program managers, project managers and other team members, building a high-performing team capable of executing complex programs effectively. Qualifications - Bachelor's degree in engineering, Business Administration, organizational leadership, or a related field. - Minimum of 20 years of experience in program management, project management, product development, or similar roles. - Minimum of 10 years’ experience as a Director of Program Management, Operations, Product Development, or similar roles. - Travel required (US and International). - Availability to attend meetings with team members spread out around the globe. - Expert of program management methodologies, including Agile and Lean principles with a proven track record of successfully managing large, complex programs from inception to completion. - Experienced and comfortable building products within Quality Management Systems (QMS) and ensuring program deliverables comply with regulatory standards. - A leader with the ability to inspire and motivate cross-functional teams with demonstrated experience in fostering a culture of empowerment and collaboration. - A problem solver with strong analytical abilities, focused on delivering practical and innovative solutions. - Superb written, verbal and visual communication skills, comfortable understanding and explaining technical topics to technical and non-technical audiences. - Strong relationship building skills and the ability to relate constructively to and influence stakeholders at all levels of an organization. - Thrives in fast-paced, complex and fluid environments with a high degree of autonomy to achieve objectives. - A can-do attitude and ability to juggle regularly changing priorities. Requirements - CSM and/or CSPO certification(s) is a plus. - Lean Six Sigma Green Belt or above. - Global experience - ability to empathize with different cultures and organizational set-ups. - Fluency in Japanese, Spanish, or German. - Experience in a high growth technology company. - Willingness to learn new technology, tools, etc. - Computer Science background or affinities. Benefits - Competitive salaries, annual bonus and 401(k)* with company match. - Comprehensive medical, dental, vision coverage effective on start date. - 24/7 Employee Assistance Program. - Free live and on-demand Wellbeing Programs. - Generous Paid Vacation and Sick Time. - Paid Parental Leave and Adoption Assistance*. - 12 Paid Holidays. - On-Site Child Daycare, Café, Fitness Center**.