Supplier Quality Engineer — Drive Bioprocessing Quality

RepliGen Corporation; Hopkinton (MA); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision insurance

Retirement benefits

Job summary

Repligen is seeking a Supplier Quality Engineer to join the Global Supplier Quality team in Massachusetts. You will evaluate supplier processes, lead audits, and drive CAPA/SCAR activities to ensure GMP and FDA compliance across the supplier network.

The role requires 2+ years in supplier quality or related fields, with strong analytical and communication skills, and willingness to travel to supplier sites. Hybrid or on-site work in MA preferred.

Qualifications

• Bachelor's degree in a technical discipline (Engineering, Quality, Life Sciences) or equivalent experience.
• 2+ years of experience in Supplier Quality, Quality Engineering, or related field.
• Experience with supplier qualification, supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.

Responsibilities

• Perform supplier qualification activities, evaluating processes, quality systems, and regulatory compliance.
• Plan and conduct supplier audits; document findings and drive corrective actions.
• Lead supplier-related nonconformance investigations and SCARs with root cause analysis.
• Evaluate supplier change notifications and coordinate cross-functional reviews.
• Monitor supplier performance using scorecards, NCMRs, SCARs, and audits.
• Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams.

Skills

Problem solving

Analytical skills

Communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Quality/Life Sciences or related

Job description

Repligen is seeking a Supplier Quality Engineer to join the Global Supplier Quality team in Massachusetts. You will evaluate supplier processes, lead audits, and drive CAPA/SCAR activities to ensure GMP and FDA compliance across the supplier network.

The role requires 2+ years in supplier quality or related fields, with strong analytical and communication skills, and willingness to travel to supplier sites. Hybrid or on-site work in MA preferred.