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