Supplier Quality Engineer II

Role: Supplier Quality Engineer II supporting contract manufacturers and raw material suppliers in the production of medical devices. Responsibilities: conduct supplier audits per GMP and ISO standards, monitor supplier performance, manage CAPA and nonconformances, oversee supplier change control and quality agreements, and collaborate with QC, manufacturing, and purchasing to drive continuous improvement and compliance. Requirements: Bachelor’s in Engineering, Life Sciences, or related field; at least 3 years in GMP/ISO-regulated industry; knowledge of medical device standards such as ISO 13485, 21 CFR Part 820; strong communication, analytical, and problem-solving skills; proficient with ERP, PLM, Microsoft Office, and statistical techniques. Preferred: experience in medical device manufacturing, process validation (IQ, OQ, PQ), and auditor certification to ISO 13485:2016; familiarity with machining, injection molding, or electro-mechanical components. HighValue: focus on supplier qualification, validation, and regulatory compliance within a regulated medical device environment. WorkSetup: not specified; role emphasizes cross-functional partner collaboration and compliance oversight.