Principal Engineer Quality

Olympus Corporation is a global medical technology company focused on improving patient outcomes through innovative solutions. The Principal Quality Engineer will lead product quality initiatives, ensuring compliance with regulatory standards and driving continuous improvement across the product lifecycle.

Responsibilities:

• 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
• 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
• 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
• 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

Requirements:

• 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
• Advanced degree preferred