Working Location: Massachusetts, Westborough; Nationwide Workplace Flexibility: RemoteJob 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 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.
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 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**
Connected Culture you can embrace:- 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
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
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.
