Sr Supplier Quality Engineer

Sr Supplier Quality Engineer Location: Campbell, California. Full time. Imperative Care is developing innovative solutions that directly impact patient outcomes in stroke treatment. What You’ll Do As a senior quality professional, this role supports Quality Engineering across the development, manufacture, and distribution of our medical device products. You will apply Quality Engineering principles to ensure compliance with FDA, ISO 13485, and internal Quality System requirements while driving continuous improvement in product or supplier performance. Collaborate with suppliers, contract manufacturers, and business partners to ensure robust materials, components, and processes. Lead supplier qualification, audits, requalification, and supplier quality agreement activities. Own and drive Supplier Quality projects, initiatives, and continuous improvement efforts. Partner with Procurement, R&D, Operations, and Supply Chain to resolve supplier-related issues and prevent disruptions. Monitor supplier performance metrics, identify risks, and drive improvement actions. Manage supplier corrective action processes (SCARs), including tracking, aging metrics, and effectiveness. Support and/or lead supplier-related CAPAs, NCRs/NCMRs, and investigations. Conduct deep failure analysis on supplier components and drive root cause and corrective actions. Implement and manage supplier change control processes, including impact assessment and approvals. Lead component and supplier qualification and change projects. What You’ll Bring Qualifications and experience required include: Bachelor’s degree in business engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and experience. Advanced degree and experience with catheters, endovascular/neurological devices are highly desired. Experience in medical devices (catheters, endovascular, or neurological) preferred. Experience in both product and supplier quality engineering strongly preferred. Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs). Demonstrated knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971), and good manufacturing practices. Excellent communication skills (both written and verbal). Proven ability to provide thorough and meticulous review of documents. Proven ability to write clear, concise, and well‑thought‑out technical documentation with a focus on failure investigations and inspection procedures. Employee Benefits Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program. Salary Range $120,000 – $151,000 per year, adjusted for location and market conditions. #J-18808-Ljbffr