Senior Supplier Quality Engineer - QA & Compliance Lead

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

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.