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- Employment
- Full-time
- Seniority
- Senior
About the role
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
- Bachelor’s Degree in Engineering required; advanced degree preferred
- 5+ years in medical device or highly regulated industry
- Demonstrated experience supporting full product lifecycle (design → launch → post-market)
- Experience in orthopedic implants or joint systems strongly preferred
- Deep understanding of:
- Design controls and lifecycle management
- Risk management (ISO 14971)
- Statistical analysis and sampling methods
- Working knowledge of:
- FDA 21 CFR Part 820
- ISO 13485 and global regulatory requirements
- Experience with
- Verification & Validation
- CAPA and root cause analysis
- Change control systems
- Familiarity with GD&T and inspection systems preferred
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