• Lead audits, consulting reviews, and Internal Controls over Financial Reporting (ICFR) testing of the Company's network of internal control processes • Lead large and complex financial, operational, and compliance audits, ICFR testing, consulting projects, fraud investigations, and special projects • Advise management regarding adequacy of control structures, and negotiate effective, efficient solutions to control weaknesses • Prepare written reports for management, executives, and the Audit Committee of the Board of Directors • Oversee and review work of internal auditors, providing leadership, coaching, and technical guidance as appropriate • Perform first level reviews of audit workpapers to ensure compliance with department and professional standards • Lead and participate in the development of a dynamic, risk-based audit plan linked to the Company's key business objectives • Accountable for execution of plan to maximize coverage of higher risk areas and issues • Analyze key financial and operating data and stay current on relevant external environmental factors, recommending changes to the audit risk environment as necessary • Develop and maintain contacts with Company management to improve and enhance Internal Auditing's partnership with management through consultation and ongoing networking • Identify or develop data analytics and enhancements to department and auditing procedures to improve the effectiveness and efficiency of the audit process

Medical Device Auditors - Full-time - USA remote with extensive travel. Interested in future career opportunities in the Quality Assurance audit and support services industry? We're looking for a Medical Device Auditor that wants to build something great with an incredible group of people. By joining Intertek, your contributions will be valued as we continue to help the world Build Back Ever Better. Intertek's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace. What are we looking for? The Auditor, Medical Devices will support the Business Assurance business by leading and/or participating as an assessor during all phases of a client’s management system, in accordance with the company’s accredited certification program. The Auditor is the primary interface with the client before and during the process of all auditing activities. Additionally, the Auditor will help train low-graded Auditors through witness audits, technical support, and education of both client and sales force as needed. This will be a travel-based position, with extensive travel to client sites required. Candidate must be comfortable traveling 3 to 5 nights per week. This is a remote position; however, applicants must reside in and be able to legally work in the United States. We are looking to hire within the next 4-6 months Salary & Benefits Information Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications, and other job-related reasons. In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more. What you’ll do: - Audit client management systems for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485, regulatory requirements for the US, Canada, Japan, Australia, and/or Brazil, and/or GMP regulatory requirements related to the medical device, pharmaceutical and/or cosmetic industry. - Assist clients with questions relevant to the audit and/or certification process. - Act as Lead Auditor or team member. - Travel will include overnight 3 to 5 days per week, to various worksites and client locations: - This will be a remote/home-based position, with extensive travel to client sites required - Travel will include overnight/multiple days, to various worksites and client locations - Coordinate audit activity with team members - Liaison with client regarding audit activity. - Review client's quality management system documentation - Verify and document evidence of compliance and non-compliance. - Prepare audit report. - Review audit results with coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required. - Assist with corrective action requirements resulting from assessments. - Participate in audit meetings. - Review audit reports and provide technical assistance to the medical team. - Support management in areas of continuous improvement. - Provide management with updates on status of work, initiatives, and projects, as required. This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties. Minimum Requirements & Qualifications: - 4 year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience. - A minimum of 4+ years of full-time work experience (design, development, testing, quality assurance/quality control) in a medical device or related medical device industry - A minimum of 2+ years in a quality management systems environment (auditing, CAPA, complaints, management review) - Completed Lead Auditor training for any standard (preferably ISO 13485 and/or relevant regulatory requirements), but will train if needed. - Strong communication and interpersonal skills. - Sound judgment, organizational, and analytical skills. - Excellent computer and writing skills. - Ability to define problems, collect data, establish facts, and draw valid conclusions. - Ability to exercise effective time management skills in completion of assignments. - Must be willing and able to travel extensively. Primarily domestic travel, some international travel may be needed. - Possess a valid unrestricted driver’s license and the ability to operate a motor vehicle in the performance of the official duties of the position. - This is a remote position; however, applicants must reside in and be able to legally work in the United States. Skills most needed: - Active Medical devices (electronics/electrical) - Software (writing/validation of software for a device or software as a medical device) - Monitoring Devices - Dental Devices and Accessories - Wound Care devices - Non-active cardiovascular implants - Non-active orthopedic implants - Non-active functional implants - Medical gas supply systems and parts thereof - Imaging/Therapeutic devices using ionized radiation - Experience with requirements for Sterilization – GAMMA/Radiation - Experience with requirements for Sterilization - EO - Experience with requirements for Sterilization - Moist and Dry heat Preferred Requirements & Qualifications: - Lead Auditor Training with (ISO19011 OR ISO13485) Certification - Related 3rd party auditing industry management systems experience. - Working knowledge of relevant regulatory requirements for medical devices and pharmaceuticals in the EU, US, Australia, Japan, Brazil, and/or Canada. - Experience implementing/auditing to ISO 13485, ISO 14971, and medical device, pharmaceutical, and/or cosmetic regulatory requirements. - Specific experience/training on processes used in the relevant industry’s manufacturing (ex. sterilization, machinery, electric and electronic devices or components, software development). - Training/experience in quality tools (Kaizen, lean manufacturing, etc.). - Working experience in a wide range of medical devices. PHYSICAL REQUIREMENTS: This role requires the ability to: - Ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms. Body agility is emphasized. - Stand, for sustained periods of time. - Walk, moving on foot to accomplish tasks and to move from one work location to another. - Communicate well, thru spoken word, conveying detailed accurate information & instructions to others. - Hear well, perceiving sounds with or without correction, including the ability to receive information thru oral communications. - Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift, carry, push, pull or otherwise move objects. - Have close visual acuity to perform an activity such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devises. Intertek: Total Quality. Assured. Intertek is a world leader in the Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion, pace, and precision we work to exceed our customers’ expectations, while engaging with our employees to be 10X in their performance and professional growth. Intertek is a drug-free workplace. As a condition of employment, certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed. We Value Diversity Intertek’s network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics. For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email hr.eeo@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department. #LI-Remote #LI-JC1 *Intertek does not accept unsolicited approaches from agencies and will not pay a fee for any placement resulting from the receipt of an unsolicited resume. Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life. The Business Assurance group of Intertek provides a full range of business process audit and support services, including management systems certification, sustainability and responsible sourcing audits, risk management, and training. Our range of bespoke auditing, performance benchmarking and supply chain solutions provide insight into every aspect of operations, allowing clients to make informed decisions about their business while ensuring their workforce competencies are current and relevant.

Role Description The Auditor, Medical Devices will support the Business Assurance business by leading and/or participating as an assessor during all phases of a client’s management system, in accordance with the company’s accredited certification program. The Auditor is the primary interface with the client before and during the process of all auditing activities. Additionally, the Auditor will help train low-graded Auditors through witness audits, technical support, and education of both client and sales force as needed. This will be a travel-based position, with extensive travel to client sites required. Candidate must be comfortable traveling 3 to 5 nights per week. This is a remote position; however, applicants must reside in and be able to legally work in the United States. What you’ll do: - Audit client management systems for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485, regulatory requirements for the US, Canada, Japan, Australia, and/or Brazil, and/or GMP regulatory requirements related to the medical device, pharmaceutical and/or cosmetic industry. - Assist clients with questions relevant to the audit and/or certification process. - Act as Lead Auditor or team member. - Travel will include overnight 3 to 5 days per week, to various worksites and client locations. - Coordinate audit activity with team members. - Liaison with client regarding audit activity. - Review client's quality management system documentation. - Verify and document evidence of compliance and non-compliance. - Prepare audit report. - Review audit results with coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required. - Assist with corrective action requirements resulting from assessments. - Participate in audit meetings. - Review audit reports and provide technical assistance to the medical team. - Support management in areas of continuous improvement. - Provide management with updates on status of work, initiatives, and projects, as required. Qualifications - 4 year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience. - A minimum of 4+ years of full-time work experience (design, development, testing, quality assurance/quality control) in a medical device or related medical device industry. - A minimum of 2+ years in a quality management systems environment (auditing, CAPA, complaints, management review). - Completed Lead Auditor training for any standard (preferably ISO 13485 and/or relevant regulatory requirements), but will train if needed. - Strong communication and interpersonal skills. - Sound judgment, organizational, and analytical skills. - Excellent computer and writing skills. - Ability to define problems, collect data, establish facts, and draw valid conclusions. - Ability to exercise effective time management skills in completion of assignments. - Must be willing and able to travel extensively. Primarily domestic travel, some international travel may be needed. - Possess a valid unrestricted driver’s license and the ability to operate a motor vehicle in the performance of the official duties of the position. Requirements - Active Medical devices (electronics/electrical). - Software (writing/validation of software for a device or software as a medical device). - Monitoring Devices. - Dental Devices and Accessories. - Wound Care devices. - Non-active cardiovascular implants. - Non-active orthopedic implants. - Non-active functional implants. - Medical gas supply systems and parts thereof. - Imaging/Therapeutic devices using ionized radiation. - Experience with requirements for Sterilization – GAMMA/Radiation. - Experience with requirements for Sterilization - EO. - Experience with requirements for Sterilization - Moist and Dry heat. Preferred Requirements & Qualifications - Lead Auditor Training with (ISO19011 OR ISO13485) Certification. - Related 3rd party auditing industry management systems experience. - Working knowledge of relevant regulatory requirements for medical devices and pharmaceuticals in the EU, US, Australia, Japan, Brazil, and/or Canada. - Experience implementing/auditing to ISO 13485, ISO 14971, and medical device, pharmaceutical, and/or cosmetic regulatory requirements. - Specific experience/training on processes used in the relevant industry’s manufacturing (ex. sterilization, machinery, electric and electronic devices or components, software development). - Training/experience in quality tools (Kaizen, lean manufacturing, etc.). - Working experience in a wide range of medical devices. Physical Requirements This role requires the ability to: - Ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms. Body agility is emphasized. - Stand, for sustained periods of time. - Walk, moving on foot to accomplish tasks and to move from one work location to another. - Communicate well, thru spoken word, conveying detailed accurate information & instructions to others. - Hear well, perceiving sounds with or without correction, including the ability to receive information thru oral communications. - Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift, carry, push, pull or otherwise move objects. - Have close visual acuity to perform an activity such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devices. Benefits - Competitive compensation packages. - Medical, dental, vision, life, disability insurance. - 401(k) with company match. - Generous vacation / sick time (PTO). - Tuition reimbursement.

Overview The Team Lead Clinical Validation Training position leads a team of Trainers focused on promoting audit accuracy measures by training/educating and mentoring the auditor and providing documented and validated findings in support of the audit’s mission and goals. The Team Lead is responsible for development and the creation of tools for centralized training methods; coordinates resources and timelines for implementations, and the ongoing training of new and current staff. This role will focus on leading Outpatient Specialty team of Trainers/Audits and our preference would be to fill this role with a nurse that already holds a coding credential. Responsibilities - Coordinates orientation and mentorship of new hire auditors to the audit review process across CCV. - Confers with audit management and/or team leads to identify training needs based on projected production processes. - Develops and/or organizes training materials for education across all lines of business including clinical validation, POS, OPSP and CMS. - Conducts and/or arranges ongoing training including technical (system) training, coding, clinical policies, medical necessity and other relevant trainings across all lines of business within CCV. - Monitors and tracks results post training for follow up educational needs. - Ensures the expected level of quality set by the department is consistently met or exceeded. Verifies completeness and accuracy of the work of direct reports. Promptly addresses and resolves issues impacting quality. - Works in collaboration with the Cotiviti Medical Directors to develop, edit/update macros and policies. Organizes and hosts monthly educational meetings. - Maintains CCV help files to provide the most up to date, accurate information across the audit. Maintains the R3 macro tool with the addition of new policies or changes/edits to existing policies. - Leads change by assessing patterns and opportunities for improvement throughout the audit. Facilitates communication across teams. - Sets priorities for educations and other projects based on business needs. - In collaboration with Quality Team Leads, tracks quality data and organizes educational plans to promote consistency with the training team and throughout the audit. - Behaves in a way that consistently demonstrates commitment to Cotiviti values. - Complete all responsibilities as outlined on annual Performance Plan. - Complete all special projects and other duties as assigned. - Hire, develop, coach, lead and retain top-tier talent, with a focus on building and improving a team and culture that is able to assist in employing best in class practices to support and drive high levels of internal and external customer satisfaction. - Complete all responsibilities as outlined in the annual performance review and/or goal setting. - Complete all special projects and other duties as assigned. - Must be able to perform duties with or without reasonable accommodation. Required Qualifications - CCS, CPC or CIC Coding certification required and maintained as a condition of employment. - Preferred - Associate OR Bachelor's degree in Nursing - 3-5 years’ experience managing employees. - Ability to mentor staff and enhance performance. - 5-7 years’ of working with ICD-9/10CM, MS-DRG, AP-DRG, and APR-DRG with a broad knowledge of medical claims billing/payment systems provider billing guidelines, payer reimbursement policies, medical necessity criteria and coding terminology. - Effective communication and presentation style (written and verbal) with proven ability to positively influence behavior and outcomes. - Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects. - Ability to multitask, set priorities and meet deadlines. - Ability to creatively solve problems, deal with ambiguity, develop and implement policy and procedures, perform analysis and prepare reports, and foster team building. - High level of proficiency with all audit technology. - Proficiency in Word, Excel, PowerPoint and other applications. - Excellent written and verbal communication skills. Mental Requirements: - Communicating with others to exchange information. - Problem-solving and thinking critically. - Completing tasks independently. - Interpreting data. - Making timely decisions in the context of a workflow. - Maintaining focus. Working Conditions and Physical Requirements: - Remaining in a stationary position, often standing or sitting for prolonged periods. - Repeating motions that may include the wrists, hands and/or fingers. - Must be able to provide high-speed internet access / connectivity and office setup and maintenance. - Must be able to provide a dedicated, secure work area. Base compensation ranges from $108,000 to $125,000 per year. This role is eligible for discretionary bonus consideration. Cotiviti offers team members a competitive benefits package to address a wide range of personal and family needs, including medical, dental, vision, disability, and life insurance coverage, 401(k) savings plans, paid family leave, 9 paid holidays per year, and 17-27 days of Paid Time Off (PTO) per year, depending on specific level and length of service with Cotiviti. For information about our benefits package, please refer to our Careers page. Date of posting: 3/16/2026 Applications are assessed on a rolling basis. We anticipate that the application window will close on 5/16/2026, but the application window may change depending on the volume of applications received or close immediately if a qualified candidate is selected.