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

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