Principal Engineer Quality

Working Location: Massachusetts, Westborough; Nationwide Workplace Flexibility: RemoteFor 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 and Empathy. Learn more about Life at Olympus: .Job DescriptionThe 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 DutiesProduct Quality LeadershipServe 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 SupportSupport 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 ControlsFacilitate and support cross-functional execution of:Process FlowchartsPFMEAsControl PlansProcedures and Work InstructionsInspection Data SheetsLead 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.Design Transfer & Validation OversightReview and approve Design Transfer Plans to ensure complete and compliant transition from development to manufacturing.Review manufacturing specifications and instructions to confirm alignment with design outputs and product requirements.Approve transfer documentation, including manufacturing processes, quality control testing measures, and defined quality requirements.Develop, oversee, review, and approve validation protocols and reports for testing methods, ensuring statistical rigor and regulatory compliance.Metrics & Continuous ImprovementEstablish and monitor key product quality metrics (e.g., complaint rates, failure trends, DPMO, CAPA effectiveness).Analyze quality data to proactively identify systemic issues and drive continuous improvement initiatives.Present quality performance, risk assessments, and mitigation strategies to senior leadership.Job QualificationsRequired: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.Why join Olympus?We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on:Competitive salaries, annual bonus and 401(k)* with company matchComprehensive medical, dental, vision coverage effective on start date24/7 Employee Assistance ProgramFree live and on-demand Wellbeing ProgramsGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption Assistance*12 Paid HolidaysOn-Site Child Daycare, Café, Fitness Center**Connected Culture you can embrace:Work-life integrated culture that supports an employee centric mindsetOffers onsite, hybrid and field work environmentsPaid volunteering and charitable donation/match programsEmployee Resource GroupsDedicated Training Resources and Learning & Development Programs Paid Educational Assistance*US Only**Center Valley, PA and Westborough, MAAre you ready to be a part of our team?Learn more about our benefits and incentives: .The anticipated base pay range for this full-time position is $106,402.00 - $148,963.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual. Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit .You Belong at OlympusWe are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact View email address on click.appcast.io. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus View phone number on click.appcast.io).Let’s realize your potential, together.It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)