jazzhr
Sr Supplier Quality Engineer
Imperative Care
Campbell, USA
Full-time
Senior Level
Onsite
USD 120000-151000 yearly
Discovered 1 weeks ago
Free
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- 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.
- 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 is 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, etc)
- 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 focus on failure investigations and inspection procedures
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