Senior Supplier Quality Engineer - Audits, CAPA & Risk

Repligen Corporation

Marlborough, Northern (MA, KY)

Hybrid

USD 130,000 - 145,000

Full time

8 days ago

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Benefits offered by this job

Bonus or commission

Equity

Paid time off

Health/dental/vision

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corporation is seeking a Senior Supplier Quality Engineer in Marlborough, MA to ensure supplier quality meets GMP and FDA expectations. You will lead supplier qualification, audits, SCAR investigations, change management, and performance monitoring while partnering with internal teams to drive risk reduction and continuous improvement.

The role requires 7+ years in supplier quality with a Bachelor’s degree in a related technical field, strong problem-solving, analytical, and

Qualifications

7+ years in Supplier Quality or related field.
Experience with supplier qualification, audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
Knowledge of quality management systems and regulatory requirements including GMP and FDA.
Ability to evaluate manufacturing processes and supplier quality systems.
Willingness to travel to supplier locations.

Responsibilities

Lead supplier qualification activities and assess supplier capabilities.
Plan and conduct supplier audits and document findings.
Investigate supplier-related nonconformances and manage SCARs.
Evaluate supplier changes and coordinate cross-functional actions.
Monitor supplier performance and drive risk reduction and improvements.
Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams.