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Quality Engineer (m/f/d)

Job Details

Zusammenfassung

  • Frankfurt am Main, Hessen
  • €80.000 - €100.000 pro Jahr
  • Festanstellung
  • Vollzeit

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Job Details

Ihre Aufgaben

  • Accountable for DHF oversight and maintenance for the post-launch stage in collaboration with the global device unit design center
  • Supporting the assessment for network impact and design consistency (e.g. DHF/DMR, Alliance impact etc.) for inter-site change controls between GDPU and network sites
  • Act as the Single Point of Contact (SPOC) for manufacturing sites of medical devices or combination products for device related Change Controls topics and operational knowledge transfer
  • Provide mentoring support to Quality Engineers, as instructed by the Manager
  • Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results
  • Ensure DHF maintenance procedures and relevant processes are robust, standardized, and adequately maintained following regulatory requirements and best practices
  • Create and maintain all DHFs structure according to defined process and system in coordination with project teams accountable for new product development or design change projects
  • Support audits or inspections requiring access to DHFs
  • Perform DHF reviews\audits as required to support Design Reviews, audit preparations or part of continuous improvement activities related to DHF maintenance process
  • Lead DHF remediation efforts
  • Lead continuous improvement projects or activities which may include product or process improvements and remediation efforts (ie DHF, Risk Management Files, etc.)
  • Contributing to network forums to support for aligned process execution in the different networks
  • Coordinating the Device & Packaging Change Board for GDPU and change control communication within the network

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