Principal Supplier Quality Engineer

Cordis•Irvine, CA

About The Position

Selution, in partnership with Cordis, develops and commercializes advanced drug-device combination products for coronary and peripheral artery disease. The Principal Supplier Quality Engineer (SQE) ensures the quality and compliance of suppliers and components used in the company’s products. The role leads supplier qualification and component approval, evaluates supplier performance, resolves non-conformances, drives corrective actions, and conducts supplier audits. It also collaborates with R&D, Operations, and Commercial teams to mitigate risks and support product development and commercialization.

Requirements

Bachelor’s degree in engineering, quality, or a related field.
At least 8 years of experience in supplier quality engineering, supplier management, or a related role.
Strong knowledge of supplier qualification, component validation, and quality systems.
Experience conducting supplier audits and working with SCAR processes.
Working knowledge of ISO 13485:2016, FDA 21 CFR Part 820 (QMSR), ISO 14971, EU MDR, and MDSAP requirements.
Excellent problem-solving, analytical, and negotiation skills.
Ability to travel up to 20% for supplier audits and collaboration.
Lead Auditor certification, such as ISO 13485 Lead Auditor, is required.

Nice To Haves

Master’s degree.
Experience in medical devices or combination products; automotive or high-tech manufacturing experience is also considered.
Six Sigma certification (Green Belt or Black Belt) and/or ASQ Certified Supplier Quality Professional (CSQP).
Proficiency in statistical analysis, FMEA, and risk management methodologies.
Clinical supplier management experience, including qualification and oversight of suppliers supporting IDE and clinical studies, such as investigational product and clinical trial material suppliers, CROs, and central labs; working knowledge of GCP and BIMO inspection readiness.
Drug or pharmaceutical supplier experience, including API and excipient suppliers under cGMP (21 CFR Parts 210/211, ICH Q7, ICH Q10) and drug-device combination product requirements (21 CFR Part 4).

Responsibilities

Lead qualification of new suppliers and ensure compliance with regulatory and company standards.
Perform supplier assessments, audits, and technical reviews to verify supplier capabilities.
Qualify components and ensure they meet product specifications and performance criteria.
Conduct periodic supplier performance reviews and track quality, delivery, and compliance KPIs.
Drive continuous improvement initiatives with suppliers to enhance quality and reliability.
Address supplier-related quality issues and ensure timely corrective and preventive actions.
Investigate supplier non-conformances and collaborate on root cause analysis.
Manage Supplier Corrective Action Requests (SCARs) and ensure effective resolution.
Implement risk mitigation strategies to prevent recurring quality issues.
Plan and execute supplier audits to ensure adherence to industry standards and company requirements.
Guide suppliers on quality expectations and compliance improvements.
Work with R&D, Operations, and Commercial teams to support supplier-related needs.
Provide technical guidance and quality input during product development and commercialization.
Act as a liaison between suppliers and internal teams to resolve quality-related challenges.