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Eindhoven - Quality Assurance Engineer

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Eindhoven - Biotechnologie - Engineer - Illumina Inc

  This position is responsible for supporting Quality Assurance and Quality Engineering activities in EMEA. Supporting product development, production, distribution and quality objectives. Basic Function and Scope of the Position:Responsible for implementing process improvement, conducting critical reliability studies, validation reviews, addressing supplier quality and new product/process development issues in support of company production and quality objectives. Tasks and Responsibilities:• Implement process improvement projects and perform critical reliability evaluation studies with no supervision.• Facilitate set up and initiation of Software Lifecycle program.• Perform internal and external compliance auditing.• Provide training of company employees on the principles of validation. statistics, sampling plans and process improvement.• Write and review validation protocols.• Review the summarized results of validation studies in final validation / engineering reports.• Interact with all personnel levels and departments to ensure full compliance with all FDA, ISO rules and regulations.• Serve as Quality core team member on project teams.• Management of corrective action program (customer complaints, audits, recalls, field corrections and process changes) to ensure timely ...


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