Bachelor's Degree in Science required; Master's Degree preferred
Minimum of 7 years experience in orthopedic or medical device field
0-5 years QA Engineering management experience in a Medical Device Company
Experience in inspection specification development and statistical techniques
Prior audit experience with FDA and notified bodies
Responsibilities
Ensure compliance with FDA, ISO 13485, MDSAP, EU MDR, and internal quality management systems
Lead and develop the Quality Engineering team to align with business objectives
Oversee design controls, risk management, verification/validation, and process validation
Drive root cause analysis and implement corrective/preventive actions for quality issues
Lead investigations and resolutions for product complaints and nonconformance
Track, analyze, and report quality metrics to support governance
Serve as a subject matter expert during audits and inspections
Benefits
Professional development opportunities
Collaborative work environment
Engagement in meaningful projects in healthcare
Supportive management fostering team success
Full Job Description
Manager, Quality Engineering
Department: 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 Expertise
Education:
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.
