Position Summary:

Reports directly to the Quality Manager, while working in close partnership with the Engineering and Operations departments to ensure seamless compliance and product quality.

Key Responsibilities:

Participate in and support external regulatory, customer, and notified body audits (including FDA, BSI, or similar registrar audits) Lead investigations using Root Cause Analysis (RCCA) and 8D Problem Solving to issue and manage Nonconformance Reports (NCR), Corrective Action Requests (CAR), and Corrective & Preventive Action (CAPA). Manage Supplier Quality Management and Quality Management Systems (QMS), including Supplier Assessments, supplier performance improvement, source inspection, and product acceptance. Analyze quality metrics, identify trends, and drive continuous improvement initiatives. Collaborate on Cross-Functional Projects to improve product quality, process capability, and manufacturing performance. Qualifications Bachelor's degree in Engineering or related technical discipline. Experience may be considered in lieu of education for exceptional candidates 3-5 years of Quality experience in medical device manufacturing. Experience with

FDA 21 CFR

Part 820/QMSR and

ISO 13485.

Strong knowledge of CAPA, root cause analysis, process validation, SPC, and risk management. Experience in a contract manufacturing (CMO/CDMO) environment preferred. Preferred Certifications ASQ Certified Quality Engineer (CQE) Six Sigma Green Belt or Black Belt Key Competencies Analytical problem-solving Attention to detail Strong communication and collaboration Customer focus Continuous improvement mindset Ability to manage multiple priorities in a fast-paced manufacturing environment