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. 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.

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. 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.

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.