Principal Supplier Quality Engineer

Cordis, LLC; Irvine (CA); Presencial; USD 112.000 - 165.000; Jornada completa

Descripción de la vacante

Cordis, LLC, in partnership with Selution, seeks a Principal Supplier Quality Engineer to ensure supplier quality across drug-device products. You will qualify new suppliers, assess components, manage performance, and drive corrective actions to meet regulatory requirements.

Collaborate with R&D and operations, lead supplier audits, and mentor teams while traveling up to 20%. The role requires a Lead Auditor certification and extensive experience in ISO 13485, FDA QSR, and EU MDR.

Formación

• Bachelor’s degree in engineering, quality, or related field.
• Minimum 8 years in supplier quality engineering or related role.
• Strong knowledge of supplier qualification, validation, and QMS.
• Experience conducting supplier audits and SCAR processes.
• Regulatory knowledge: ISO 13485, FDA QMSR, EU MDR.
• Willing to travel up to 20% for audits.
• Lead Auditor certification required.

Responsabilidades

• Lead supplier qualification processes.
• Perform supplier assessments, audits, and reviews.
• Qualify components to specs and performance criteria.
• Manage supplier performance, non-conformances, and CAPAs.
• Plan and execute supplier audits per standards.

Conocimientos

Supplier qualification

Audits

SCAR processing

Regulatory compliance

Travel up to 20%

Educación

Bachelor’s degree in engineering or quality

Master’s degree preferred

Lead Auditor certification

Herramientas

Lead Auditor certification

Descripción del empleo

Overview

Selution, in partnership with Cordis, specializes in the development of groundbreaking technology and commercialization of advanced drug-device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The Principal Supplier Quality Engineer (SQE) will be responsible for ensuring the quality and compliance of suppliers and components used in the company’s products. This role involves qualifying new suppliers, assessing component quality, managing supplier performance, resolving non-conformances, driving corrective actions, and conducting supplier audits. The Principal SQE will also collaborate closely with R&D and commercial teams to mitigate risks and ensure smooth project execution.

Job Summary and Responsibilities

Supplier Qualification & Component Approval

• Lead the qualification process for new suppliers and ensure compliance with regulatory and company standards.
• Perform supplier assessments, audits, and technical reviews to verify capabilities.
• Qualify components and ensure adherence to product specifications and performance criteria.

Supplier Performance & Compliance Management

• Conduct periodic supplier performance reviews, tracking KPIs such as quality, delivery, and compliance.
• Drive continuous improvement initiatives with suppliers to enhance quality and reliability.
• Address and resolve supplier-related quality issues, ensuring timely corrective and preventive actions.

Non-Conformance & Corrective Action Management

• 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.

Supplier Audits & Compliance

• Plan and execute supplier audits to ensure adherence to industry standards and company requirements.
• Ensure supplier processes align with ISO 13485, FDA 21 CFR Part 820 (QMSR), 21 CFR Part 4 combination product requirements, EU MDR, and other applicable regulations.
• Provide guidance to suppliers on quality expectations and compliance improvements.

Cross-Functional Collaboration

• Work closely 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.

Qualifications

Requirements

• Bachelor’s degree in engineering, quality, or a related field. Master’s degree preferred.
• Minimum of 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 regulatory and compliance requirements, including ISO 13485:2016, FDA 21 CFR Part 820 (QMSR), ISO 14971, EU MDR, and MDSAP.
• Excellent problem-solving, analytical, and negotiation skills.
• Ability to travel up to 20% for supplier audits and collaboration.
• Lead Auditor certification (e.g., ISO 13485 Lead Auditor) required.

Preferred Qualifications

• 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 (e.g., investigational product and clinical trial material suppliers, CROs, central labs), with working knowledge of GCP and BIMO inspection readiness.
• Drug/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).

Pay / Compensation

The expected pre-tax pay rate for this position is $111,650 - $165,000 per year.
Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge, and location.

Cordis will consider providing visa sponsorship for the right candidate.