Manager, Quality EngineeringDepartment: Quality
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Director, Quality Management Systems
Description The Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring individuals and teams while creating an environment of organizational excellence to deliver results.
Key Responsibilities- Quality & Regulatory Compliance: Ensure alignment with FDA, ISO 13485, MDSAP, EU MDR, and internal QMS; maintain audit readiness and certification compliance.
- Quality Engineering Leadership: Lead and develop the Quality Engineering team; align goals, performance, and resources to business objectives.
- Product Realization (Design & Manufacturing): Oversee design controls, risk management, verification/validation, and process validation; ensure compliance with GD&T, inspection, and statistical requirements.
- CAPA & Investigations: Drive root cause analysis, corrective/preventive actions, and cross-functional resolution of quality issues.
- Complaints & Nonconformance: Lead investigation, containment, disposition, and timely resolution of complaints and nonconforming product; escalate risks as needed.
- Data & Reporting: Track, analyze, and report quality metrics; support Management Review and Quality Governance.
- Audit Support: Serve as SME during internal and external audits/inspections.
Skills Knowledge and ExpertiseEducation:- Bachelor's Degree in Science from an accredited institution required; Master's Degree preferred
Experience:- Minimum of 7 years experience, preferably in orthopedic or other medical device field.
- Working understanding and leadership capability to ensure Quality System requirements are implemented and measured for effectiveness.
- Minimum of 0-5 years prior QA Engineering management experience in a Medical Device Company.
- Experience in inspection specification development, statistical techniques, gage R&R, and G,D&T applications
- Prior audit experience with FDA and notified bodies.
Functional/Technical Knowledge, Skills and Abilities Required:- Excellent verbal, written communication and leadership skills.
- Ability to work with all organizational functions.
