Sr. Quality Engineer
Advita Ortho•Gainesville, FL
•Onsite
About The Position
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.
Requirements
- Bachelor’s Degree in Engineering required
- 5+ years in medical device or highly regulated industry
- Demonstrated experience supporting full product lifecycle (design → launch → post-market)
- 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 CAPA and root cause analysis, Change control systems
Nice To Haves
- advanced degree preferred
- Experience in orthopedic implants or joint systems strongly preferred
- Familiarity with GD&T and inspection systems preferred
- Experience with Verification & Validation
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
