Role Description The Senior Staff Specialist, Quality eSystems is responsible for the strategic development, governance, and continuous improvement of global Quality Management System (QMS) electronic systems that support Regulatory Affairs and Quality functions. This role serves as a key business partner to Global Process Owners (GPOs), Divisional Process Owners (DPOs), and Enterprise Digital Technologies (EDT) to ensure enterprise systems are effective, compliant, scalable, and aligned with current and future business needs. - Serve as the Business System Owner and Subject Matter Expert (SME) for global Quality eSystems, supporting enterprise system governance, data management, and system integrations. - Partner with Global Process Owners, Divisions, and Enterprise Digital Technologies to define, implement, and optimize enterprise system capabilities. - Evaluate enterprise system interfaces and dependencies, ensuring integrations are documented, maintained, and escalated when issues arise. - Drive initiatives that improve the efficiency, effectiveness, and compliance of global Quality Management System processes and technologies. - Assess current and future business requirements and recommend system enhancements that support global operational needs. - Support enterprise-wide projects, system implementations, validation activities, and achievement of key project milestones. - Provide guidance on system changes required to support regulatory requirements, process improvements, and business transformation initiatives. - Partner with stakeholders to develop training, governance, metrics, and communication strategies that promote compliant and effective eSystem usage. Qualifications - Bachelor’s degree in Science, Engineering, Business, or a related discipline. - Minimum 6 years of experience supporting global Quality Management Systems (QMS) or electronic systems. - Experience working in a regulated medical device, pharmaceutical, biotechnology, or related industry. - Experience supporting cross-functional, cross-site, or global projects. - Knowledge of U.S. and international medical device regulations and quality system requirements. - Experience supporting enterprise systems, system integrations, and business process optimization. - Experience participating in quality audits, compliance activities, or validation processes. - Experience working with Quality Management Systems within a regulated environment. Requirements - Experience serving as a business system owner or subject matter expert for enterprise Quality systems. - Experience partnering with Enterprise Digital Technologies or Information Technology organizations. - Experience supporting global process ownership and enterprise business transformation initiatives. - Experience developing training, system governance, and change management strategies. - Experience supporting GxP-regulated systems and compliance requirements. - Experience utilizing quality metrics and data-driven decision making. - Experience working across multiple geographies and time zones. - Formal project management training or experience leading enterprise system initiatives. Benefits - United States of America Pay Ranges: - Puerto Rico: $89,300 - $148,800 USD Annual - USN: $95,700 - $159,500 USD Annual - US5: $100,500 - $167,500 USD Annual - US10: $105,300 - $175,500 USD Annual - US15: $110,100 - $183,400 USD Annual - US20: $114,800 - $191,400 USD Annual - US30: $124,400 - $207,400 USD Annual - Travel Percentage: 10%

Role Description The Clinical Retention Specialist is a clinically driven retention role focused on strengthening long term adoption of Omnipod® products and improving health and quality of life outcomes for people living with diabetes. This position blends deep clinical expertise, consultative selling, and relationship management to retain customers through high impact education, proactive issue resolution, and personalized clinical support. The ideal candidate is a dynamic, results oriented clinical educator who thrives in a fast paced, high volume phone/virtual environment and partners closely with internal teams and healthcare providers. Through value driven clinical conversations, this role reinforces confidence in Omnipod therapy and proactively addresses barriers to long term use. Operates as an individual contributor without formal people management responsibility. Requires independent judgment in managing day to day customer interactions, prioritizing outreach, and delivering clinical education within defined parameters. Qualifications - Bachelor’s degree required. - Active, professional clinical credentials required, such as: - Registered Nurse (RN) - Registered Dietitian (RD) - 3+ years of experience training and/or supporting insulin pump patients. - Direct experience working with healthcare providers in a diabetes care setting. - Current Certified Diabetes Care and Education Specialist (CDCES) credential required. - Ability to maintain all required professional licensure and Omnipod product certifications. - Demonstrated ability to communicate effectively and persuasively with diverse audiences via phone and virtual platforms. Requirements - Strong clinical acumen with expertise in diabetes technology and data interpretation. - Excellent phone presence with exceptional interpersonal, customer service, and communication skills. - Consultative, influence based approach to customer engagement and retention. - Proven ability to build trust and long term relationships in a remote, phone based environment. - Strong problem solving, workflow optimization, and objection handling skills. - Self directed, process oriented, and adaptable in a fast paced retention focused setting. - Proficiency in Microsoft Office and Salesforce. - Prior industry, commercial, or sales adjacent clinical experience strongly preferred. Benefits - Medical, dental, and vision insurance - 401(k) with company match - Paid time off (PTO) - Additional employee wellness programs Compensation For U.S.-based positions only, the annual base salary range for this role is $79,300.00 - $118,900.00. This position may also be eligible for incentive compensation. Application Details This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online.

Role Description It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. - Take ownership of assigned aspects of quality reviews on projects. - Compile metrics and identify quality trends. - Assist in addressing periodic client quality reviews and other ad-hoc client quality findings. - Prepare initial drafts of Corrective and preventive actions. - Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. - Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). - Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. - Take ownership of assigned CAPAs with respect to ensuring that the actions are closed and produce documentary evidence to that effect in coordination with the project managers. - Contribute to process reviews, own certain aspects of the reviews and use the results to help identify process improvements and develop process standards. - Contribute to designing and tracking training schedule and training material for new hires and existing team. - Help initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects. - Assist in coordinating respective client or external audits of the assigned projects. - Draft sections of the Quality Management Plan for assigned project. - Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager. - Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. - Respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. - Review recorded information that may be received over the telephone call, email, fax etc. - Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up. - Guide safety associates in managing voice calls (as required). - Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. - Perform Analysis of data and if required, suggest strategies for process improvement/excellence. - Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. - All other duties as needed or assigned. Qualifications - Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Requirements - Four Years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least One year of experience in Peer review/Quality review. - Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. - In-depth understanding of case processing and assessment. - Knowledge of Quality Assurance. - Awareness of lean methodology concepts. - Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include - Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. - Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective is preferred. Physical Demands/Work Environment - Office Environment or remote. - Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.

Role Description To ensure smooth, efficient, and high-quality production of automotive Connector Car and Car Audio products through effective planning, monitoring and optimization of the assembly lines. Act for implementation of production processes and procedures, leading productivity improvements, including new product introduction and manufacturing cell design to reduce waste, improve safety, quality, and delivery performance. In this role, you will report to the Manager, Production and Operation. What You Will Do - Manage daily operations for SMT & THT lines manufacturing. - Set up, optimize & monitor SMT as well as THT production lines. - Monitor production targets, cycle time and manpower planning to ensure output meets demand. - Monitor, control and improve Production KPI - OEE, First pass yield, DL efficiency, Component Droppage, Scrap rate. - Implement and maintain Standard Operating Procedures (SOPs) and Work Instructions (WI). - Ensure compliance with IATF 16949, ISO 9001, ISO 14001, ISO 45001 and ESD standards. - Coordinate with Quality and Engineering teams to address in-process defects, deviations, and audits. - Support PPAP, FMEA, and root cause analysis (RCA) for production issues. - Lead Kaizen and continuous improvement initiatives (Lean, 5S, Poka-Yoke, SMED). - Optimize layout and workflow to reduce cycle time and waste. - Monitor health and performance of assembly fixtures, jigs, tools and automated stations. - Coordinate with maintenance for timely breakdown maintenance. - Support NPI (New Product Introduction) and equipment validation activities. - Train operators on new product assembly processes, safety, and quality norms. - Ensure adherence to HARMAN’s safety policies and promote a culture of zero harm. - Supervise daily work and performance of line operators and contract workforce. Qualifications - Diploma/B.E./B. Tech in Electronics, Electrical or related. - Experience: 5–8 years in SMT operations within automotive electronics. - Familiar with PCBA Manufacturing process. - Hands-on with SAP PP/MM, MS Office, and data reporting tools. - Strong problem-solving, analytical thinking, team coordination and communication. Benefits - Flexible work environment, allowing for full-time remote work globally for positions that can be performed outside a HARMAN or customer location. - Access to employee discounts on world-class Harman and Samsung products (JBL, HARMAN Kardon, AKG, etc.). - Extensive training opportunities through our own HARMAN University. - Competitive wellness benefits. - Tuition reimbursement. - “Be Brilliant” employee recognition and rewards program. - An inclusive and diverse work environment that fosters and encourages professional and personal development.