Bachelor's degree in engineering, quality, or related field; Master's preferred.
8+ years of experience in supplier quality engineering or management.
Strong knowledge of supplier qualification and quality systems.
Experience with supplier audits and SCAR processes.
Familiarity with ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.
Excellent problem-solving and negotiation skills.
Lead Auditor certification required.
Responsibilities
Lead supplier qualification processes to ensure compliance with standards.
Perform audits and assessments to verify supplier capabilities.
Conduct periodic reviews of supplier performance metrics.
Drive continuous improvement initiatives with suppliers.
Investigate non-conformances and manage corrective actions.
Plan and execute supplier audits for compliance verification.
Collaborate with cross-functional teams to address supplier-related challenges.
Benefits
Opportunity for professional growth in a dynamic environment.
Collaborative work culture with cross-functional teams.
Potential for travel to engage with suppliers.
Exposure to regulatory compliance in medical devices and pharmaceuticals.
Full Job Description
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.
