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Supplier Quality Engineer

Repligen · Hopkinton, MA

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QualityFull-time$80k–$105kCompany career page

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Role summary

Repligen seeks a Supplier Quality Engineer to manage qualification, audits, and performance of its global supplier network. The role involves ensuring compliance with regulatory standards, investigating quality issues, and supporting cross-functional teams in a fast-paced bioprocessing environment.

What they're looking for

  • Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline
  • 2+ years supplier quality, quality engineering, or manufacturing quality experience
  • Experience with supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis
  • Knowledge of quality management systems, GMP, and FDA regulatory requirements
  • Ability to evaluate manufacturing processes, technical documentation, and quality systems
  • Strong problem-solving, analytical, and cross-functional collaboration skills
  • Willingness to travel to supplier locations as required

What you'll be doing

  • Conduct technical evaluations and qualification activities for new and existing suppliers
  • Plan and execute supplier audits, document findings, assess risk, and track corrective actions
  • Lead nonconformance investigations and supplier corrective action requests with root cause analysis
  • Evaluate supplier change notifications and assess quality and regulatory impact
  • Monitor supplier performance through scorecards and key performance indicators

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