Senior Supplier Quality Engineer

Merck & Co.; Marlborough (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Repligen is seeking a Senior Supplier Quality Engineer to ensure suppliers meet quality, regulatory, and technical requirements. You will lead supplier qualification, audits, and CAPA/SCAR processes across functions.

Travel to supplier locations, review SCNs, assess impact of changes, monitor scorecards and risk, and collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related discipline.
• 7+ years in Supplier Quality or related field.
• Experience with supplier qualification, audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
• Knowledge of GMP and FDA requirements.
• Ability to travel to supplier locations.

Responsibilities

• Conduct supplier qualification evaluations of processes, capabilities, and quality systems.
• Plan and conduct supplier audits and document findings.
• Lead SCAR investigations and corrective action follow-up.
• Evaluate SCNs and coordinate cross-functional change actions.
• Monitor supplier performance via scorecards and KPIs.
• Perform supplier risk assessments and support development plans.
• Collaborate with QA, Sourcing, Engineering, Operations, and Regulatory teams.

Skills

Supplier Quality

Audits

Nonconformance investigations

CAPA/SCAR

Root cause analysis

Cross-functional collaboration

Travel readiness

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Job description

The Senior Supplier Quality Engineer is responsible for ensuring suppliers meet Repligen quality, regulatory, and technical requirements.

• Supplier Qualification: Conduct technical evaluations and qualification activities for new and existing suppliers, including assessment of manufacturing processes, capabilities, quality systems, and compliance with Repligen requirements.
• Supplier Audits: Plan and conduct supplier audits, document findings, assess risk, and follow through on corrective actions and improvement opportunities.
• Supplier Quality Issues: Lead supplier-related nonconformance investigations and Supplier Corrective Action Requests (SCARs), including root cause evaluation, corrective action follow-up, and effectiveness verification.
• Supplier Change Management: Evaluate Supplier Change Notifications (SCNs), assess quality and regulatory impact, and coordinate cross-functional reviews and required actions.
• Supplier Performance: Monitor supplier quality performance and trends through scorecards, NCMRs, SCARs, audit results, and other key performance indicators. Partner with suppliers to address performance gaps.
• Supplier Risk and Development: Perform supplier risk assessments and support development plans for key and critical suppliers to reduce quality and supply risk and improve supplier capability.
• Cross-Functional Partnership: Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams on supplier qualification, product and process validation, supplier changes, and quality improvement activities.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent relevant experience.
• 7+ years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related field.
• Experience with supplier qualification, supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
• Working knowledge of quality management systems and applicable regulatory requirements, including GMP and FDA requirements.
• Ability to evaluate manufacturing processes, technical documentation, and supplier quality systems.
• Strong problem-solving, analytical, communication, and cross-functional collaboration skills.
• Ability to travel to supplier locations as required.

Preferred Qualifications

• Experience within life sciences, biopharmaceutical manufacturing, medical devices, or another regulated industry.
• ASQ certification, Lead Auditor certification, or similar quality certification.
• Experience with statistical methods, process capability, validation, or continuous improvement tools.