Senior Quality Engineer

Senior Quality Engineer | Orthopedic Joint Implants | On-site, Florida US | Competitive Salary This is the Quality owner for a defined orthopedic joint portfolio (Knee, Hip, or Shoulder) at an established medical device manufacturer. You will provide end to end quality engineering support across the full product lifecycle, ensuring quality, compliance, and risk management from design through post-market. What you will own Quality Engineering leadership for a designated product line across the full lifecycle, from development through post-market support Quality activities for new product development, ensuring FDA, ISO, and design control compliance Risk management including DFMEA, hazard analysis, and lifecycle risk file maintenance (ISO 14971) Verification and validation strategy, execution, and documentation Design transfer and product launch, including inspection methods, control strategies, and process validation (IQ/OQ/PQ) Sustaining engineering activities, including nonconformances, CAPAs, and customer complaints Change control, root cause analysis, and continuous improvement using a risk-based approach. What you must have 5+ years in medical device or another highly regulated industry Demonstrated experience supporting the full product lifecycle (design, launch, post-market) Deep understanding of design controls, risk management (ISO 14971), and statistical analysis and sampling methods Working knowledge of FDA 21 CFR Part 820, ISO 13485, and global regulatory requirements Experience with verification and validation, CAPA, and change control systems #J-18808-Ljbffr Skills Alliance