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Quality Engineer

3 months ago

Waltham, United States Priority Search Full time

We are working on an exciting opportunity to join this Boston area commercial medical device combination product company. Our client uses its proprietary technology platform to support a broad pipeline of products, with an initial focus on pancreatic insufficiency which results in malabsorption common in digestive cancers, and other serious diseases.

Responsibilities:

  • Provide quality support to R&D and Tech Ops group during design transfer of new product/s and routine production.
  • Collaborate with Tech Ops group to create/review the design transfer plan.
  • Support new equipment/process/site qualification at the CMO. Assist in process and software validation at the CMO,.
  • Review/approve process qualification plans, PFMEA, Control Plans, and associated reports.
  • Create/review various design/manufacturing control related documents and ECOs in eQMS system.

Education and Experience:

  • Bachelor’s Degree in Science or Engineering
  • 2-4 years of experience in quality assurance in medical device or related life science industry.