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Kestra Medical, founded in 2014, develops innovative wearable cardiac medical devices combining modern technology with proven device therapies. The Senior Supplier Quality Engineer will be responsible for managing supplier quality across the product lifecycle, from development through commercialization.
Key responsibilities include leading supplier audits, selection, and development activities; participating in design reviews to ensure manufacturability and define critical-to-quality parameters; managing supplier part and assembly qualifications using PFMEA, AQPQ, and PPAP methodologies; and overseeing supplier process validation using IQ/OQ/PQ techniques. The role requires approving supplier test and inspection plans, maintaining supplier KPIs and scorecards, driving quality improvements, managing MRB dispositions and 8D corrective actions, and implementing Six Sigma and lean manufacturing techniques.
The engineer will act as the primary technical contact for assigned suppliers, working independently and collaboratively with supply chain and development teams. Responsibilities include maintaining compliance with Kestra's Quality Management System and managing technical projects related to audits, PPAP submissions, SCARs, and other deliverables to meet internal deadlines.
Required qualifications include a bachelor's degree in electrical engineering, material science, or equivalent technical field; 8+ years of directly relevant experience in FDA/cGMP regulated environments; working knowledge of PPAP and IQ/OQ/PQ validation; strong communication skills; direct experience as a manufacturing, test, or supplier quality engineer; and advanced Excel or statistical software proficiency. Preferred experience includes 8+ years in FDA-regulated environments and familiarity with high-level quality systems best practices.
