Supplier Quality Engineer

About the role

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. To learn more about Supira Medical, please visit www.supiramedical.com.

Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the fields of cardiology and ophthalmology.

Responsibilities

• Collaborate with suppliers, contract manufacturers, and business partners to ensure robust materials, components, and processes.
• Participate in 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.

Qualifications

• 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.

Skills

• 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.

Pay

The hourly pay range for this temporary position is between $32 and $40 per hour.