Manager, Quality Engineering

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 & Expertise

• Bachelor’s Degree in Science from an accredited institution required; Master’s Degree preferred

• 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.

• Excellent verbal, written communication and leadership skills.
• Ability to work with all organizational functions.