Supplier Quality Engineer

Shifamed; Los Gatos (CA); On-site; USD 69,000 - 83,000; Full time

Job summary

Supira Medical, a clinical-stage Shifamed Portfolio Company, is seeking a Supplier Quality Engineer to ensure supplier and component quality for a high-flow pVAD. This is a three-month contract with full-time hours (40 hours per week).

You will collaborate with suppliers and cross-functional teams to drive quality improvements and change controls. The role requires a Bachelor’s in engineering and 5+ years in supplier or product quality within medical devices.

Qualifications

• Bachelor’s degree in engineering and 5+ years in related field.
• Experience with FDA QMSR, ISO 13485/9001, ISO 14971.

Responsibilities

• Collaborate with suppliers, contract manufacturers, and partners to ensure robust materials, components, and processes.
• Lead supplier qualification, audits, requalification, and supplier quality agreements.
• 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 and effectiveness.
• Support and/or lead supplier-related CAPAs and NCRs.

Skills

Communication skills

Root cause analysis

Collaboration

Education

Bachelor's in engineering

Tools

SCAR tracking

CAPA management

Job description

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.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description:

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. This temporary position is a three (3) month contract with full-time hours (40 hours per week).

Responsibilities, Skills, & Hands-on Experience:

• 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.

Education & Work Experience:

• 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.

Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The hourly pay range for this temporary position is between $50-$60 per hour.

NOTICE TO CANDIDATES:

Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [e-mail].