Quality Engineer – Medical Device

Location: Chennai
Educational Qualification: B.E./B.Tech, or any equivalent
Experience: 4 to 8 Years
Tools: Minitab (good to have)

Skills and Abilities

  • Knowledge on QMS standards like ISO 9001 and ISO 13485
  • Extensive knowledge in 21.CFR.820.30 design control process, EUMDR
  • Hands on experience in Risk management activities with respect to ISO 14971
  • Typically requires a minimum of a Bachelor’s Degree.
  • A minimum of 8 years meaningful experience or a combination of equivalent education and proven

Roles and Responsibilities

  • Project Execution
  • Understand the client requirements
  • Technical review
  • Communicate with the clients or Customer SPOC
  • QMS Compliance
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