Principal Engineer Quality

Job 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.

Job Qualifications

• Required:
• 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

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings include competitive salaries, annual bonus and 401(k) with company match, comprehensive medical, dental, vision coverage, 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, and more. Connected Culture includes work-life integrated culture, onsite, hybrid and field work environments, paid volunteering and charitable donation/match programs, Employee Resource Groups, dedicated Training Resources and Learning & Development Programs, and Paid Educational Assistance.

Pay Range

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.

Company Information

Olympus is a global medical technology company committed to making people's lives healthier, safer, and more fulfilling. Founded in 1919, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, headquartered in Center Valley, Pennsylvania, USA, employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

Equal Opportunity Employer

We are 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 OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).