Data & Reporting: Track, analyze, and report quality metrics; support Management Review and Quality ... Bachelor's Degree in Science from an accredited institution required; Master's Degree preferred ...
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Data & Reporting: Track, analyze, and report quality metrics; support Management Review and Quality ... Bachelor's Degree in Science from an accredited institution required; Master's Degree preferred ...
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Job 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.
- 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.
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.