Supplier Quality Engineer

Shifamed • Los Gatos, CA

7d

About The Position

Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. The Supplier Quality Engineer will ensure products and services provided by suppliers meet quality standards. This position represents an exciting opportunity to join an innovative company and shape its supplier management process. As the key member of quality team, you will be taking a variety of quality responsibilities, including working with other members of the procurement and operations team, and other duties as assigned.

Requirements

• Bachelor’s degree in engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and experience.
• 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 is strongly preferred.
• Experience addressing supplier or process issues (NCRs, SCARs, etc.)
• Demonstrated knowledge of quality system requirements (FDA QMSR, 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.

Responsibilities

• Collaborate with suppliers, contract manufacturers, and business partners to ensure robust materials, components, and processes.
• Participate with 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, nonconformances (NCRs), and investigations.
• Conduct 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level