The Sr. Quality Engineer serves as the Quality owner for a defined orthopedic joint product portfolio (e.g., Knee, Hip, Shoulder), providing end-to-end quality engineering support across the full product lifecycle. This role ensures quality, regulatory compliance, and risk management from design through post-market support.
Key Responsibilities
Serve as the Quality Engineering lead for a designated product line, ensuring product quality and compliance across the full lifecycle—from development through post-market support
Lead quality activities for new product development, ensuring compliance with FDA, ISO, and design control requirements
Partner with R&D to translate user needs into quality requirements, identify critical-to-quality characteristics, and support design reviews
Drive risk management activities, including DFMEA, hazard analysis, and lifecycle risk file maintenance (ISO 14971)
Lead verification & validation strategy, execution, and documentation
Support design transfer and product launch, including inspection methods, control strategies, and process validation (IQ/OQ/PQ)
Collaborate with Supply Chain on supplier qualification and readiness
Act as the Quality lead for sustaining engineering activities, including investigation and resolution of nonconformances, CAPAs, and customer complaints
Analyze product and field performance data to identify trends, risks, and improvement opportunities
Lead change control activities to ensure continued product quality and compliance
Drive root cause analysis and continuous improvement initiatives using a risk-based approach
Serve as a cross-functional Quality SME, partnering with R&D, Manufacturing, Regulatory, Clinical, and Marketing teams
Support audits and provide mentorship or technical guidance to junior engineers
Skills Knowledge and Expertise
Education:
Bachelor’s Degree in Engineering required; advanced degree preferred
Experience:
5+ years in medical device or highly regulated industry
