Sr. Quality Engineer

Sr.

Quality Engineer Department:

Quality Employment Type:

Full Time Location:

Gainesville, FL Reporting To:

Manager, Quality Engineering Description 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 Demonstrated experience supporting full product lifecycle (design → launch → post-market) Experience in orthopedic implants or joint systems strongly preferred

Functional/Technical Knowledge, Skills and Abilities Required:

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