Global Supplier Quality Engineer – Audit & CAPA Lead

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

Job summary

Repligen is seeking a Supplier Quality Engineer to join the Global Supplier Quality team in the U.S. You will evaluate supplier processes, manage qualifications and audits, lead SCAR investigations, and drive corrective actions to ensure GMP/FDA compliance across the supplier base.

The role reports to the Senior Director of Global Supplier Quality and is based in Massachusetts (Waltham or Hopkinton). The successful candidate will partner with Quality, Sourcing, Engineering, and Regulatory teams,

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 2+ years in Supplier Quality, Quality Engineering, or related field.
• Experience with supplier qualification, audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
• Knowledge of GMP and FDA regulatory requirements.
• Ability to evaluate manufacturing processes and supplier quality systems.
• Strong problem-solving and cross-functional collaboration skills.

Responsibilities

• Qualifications and qualification activities for new/existing suppliers.
• Plan and conduct supplier audits and document findings.
• Lead SCAR investigations, corrective actions, and verification.
• Evaluate SCNs and coordinate cross-functional actions.
• Monitor supplier performance via scorecards and KPIs.
• Perform supplier risk assessments and development plans.

Skills

Supplier quality

Root cause analysis

Cross-functional collaboration

Communication

Analytical thinking

Travel flexibility

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related field

Tools

QMS

CAPA tools

Job description

Repligen is seeking a Supplier Quality Engineer to join the Global Supplier Quality team in the U.S. You will evaluate supplier processes, manage qualifications and audits, lead SCAR investigations, and drive corrective actions to ensure GMP/FDA compliance across the supplier base.

The role reports to the Senior Director of Global Supplier Quality and is based in Massachusetts (Waltham or Hopkinton). The successful candidate will partner with Quality, Sourcing, Engineering, and Regulatory teams,