Job Description

  • Be a part of sustaining project team and work in the design quality engineering across the entire product cycle.
  • Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable)
  • Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products.
  • Manage electronic document control and version control on all project related documents.
  • Ensure adherence to the quality systems and design assurance SOPs and customer's PLCP.
  • Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
  • Lead in...

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