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Senior Quality Engineer

Company: Cypress HCM
Location: Eden Prairie
Posted on: July 31, 2022

Job Description:

  • Product Development Support
  • Influence Design Controls and Risk Management development to ensure appropriate manufacturability/ sustainability
  • In-Process Inspection Test Method Validation protocols, testing, reporting
  • Drive PFMEA, OQ, PQ with Process Development Engineer assistance
  • Development of in-process inspections
  • Support of Supplier and Material Qualification Activities (incl. FAIRs and incoming inspection procedures) with Supplier Quality as owner
  • Takes on ownership of Risk Management maintenance with Production Transfer.
  • Operations Support
  • Support materials receiving and inspection activities with Supplier Quality as owner.
  • Ensure quality of produced products by understanding production process and performing/reviewing in-process and finished goods inspections.
  • Release of sterile product by reviewing sterilization results and addressing any non-conformances.
  • Draft and route a variety of protocols and reports for product, processes, manufacturing events, and equipment changes/activities.
  • Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
  • Support controlled facilities environment by participating in environmental monitoring, calibration, and preventive maintenance activities.
  • Perform equipment qualification for any new and changing equipment requirements

Keywords: Cypress HCM, Eden Prairie , Senior Quality Engineer, Engineering , Eden Prairie, Minnesota

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