Design Quality Engineer

תיאור התפקיד

As a Design Quality Engineer, you will be ensuring that the design control requirements are fulfilled as part of PDP and CDP projects team

  • You will manage the risk management activities from the early stages of the development process and throughout the product lifecycle.
  • You will review and approve product Verification and Validation strategy
  • You will review and approve design documents and processes in accordance with Design Controls standards and company’s policies.
  • You will track product Standards to guide others on their correct implementation.
  • You will Implement statistical tools usage in R&D, e.g. Cpk, MSA, DOE.

דרישות התפקיד

  • BSc Engineering degree or higher
  • At least 2 years prior experience related to design quality in a medical device company
  • Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971 and the Medical Device Directive
  • Experience in risk evaluation techniques, e.g. FMEA, fault tree analysis
  • Reliability analysis and test methods
  • Working knowledge of  software and electrical medical devices related standards, IEC62304, IEC 60601, usability and human factors standards
  • Demonstrated scientific analysis abilities
  •  6 sigma Certificate is an advantage

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