Job Description

Excellent opportunity to join a thriving medical device company growing their quality assurance department!

Key Responsibilities:

• Design and execute quality assurance strategies for mechanical systems, parts, and product evaluations.
• Carry out inspections, testing, and audits to ensure alignment with both internal and external quality standards and regulations (e.g., FDA’s 21 CFR 820, ISO 13485 & ISO 9001, etc.).
• Lead investigations into defect origins and guide corrective actions.
• Conduct GD&T assessments on tolerance stack-ups.
• Perform validation of components both at suppliers' locations and internally, including preparing detailed protocols and reports based on statistical evaluation.
• Lead and assess suppliers during on-site audits to verify adherence to regulatory, FDA, GMP, and ISO guidelines, documenting audit results and supervising corrective measures.
• Monitor supplier performance metrics, including defect rates and quality throughput.
• Collaborate with suppliers to address non-conformances and implement continuous improvements via Supplier Corrective Action Requests (SCARs).
• Support Quality Management System (QMS) activities and organizational development, including participation in Material Review Board (MRB) meetings, batch reviews, product releases, and Corrective and Preventive Action (CAPA) investigations.

Qualifications:

• BS in Mechanical Engineering, Engineering, Quality Management, or a similar field
• 6+ years of experience in quality assurance for medical devices.
• Extensive experience in quality management within a medical device manufacturing environment, ideally with knowledge of GMP, QSR, ISO, MDD, and MDR regulations.
• Certifications such as Six Sigma Green/Black Belt or ASQ CQE are highly desirable.
• In-depth knowledge of FDA regulations, particularly 21 CFR 820.
• Knowledge of investigative tools like the 5-Whys, Fishbone Diagrams, Turtle Diagrams, etc.
• Advanced understanding of statistical methods.

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