Quality Assurance Engineer

  • location: Mansfield, MA
  • type: Contract
  • salary: $37 - $42 per hour

job description

Contract position: Design Assurance Quality Engineer needed for a direct position in southeast area of Boston Massachusetts for a temp to direct opportunity. Candidate will work on new product development and improvement teams by communicating quality/compliance requirements, developing procedures, creating planning documents, approving specifications and providing technical transfer/validation support. Candidate must have 5 years experience in electro-mechanical medical devices. This is a great opportunity to work with a well established medical service company.

Responsibilities for the Quality Assurance Engineer

  • Develop Risk Management Plans for new medical devices
  • Conduct design and process Failure Mode and Effects Analysis and hazard analysis, with development team subject matter experts
  • Create Verification and Validation Plans and test plans, as directed by project manager
  • Design and develop sampling plans and provide statistical guidance, where needed, during the development process
  • Plan, develop and execute IQ/OQ/PQs for equipment and processes utilized during design verification, validation and manufacturing
  • Trace design requirements to resultant outputs
  • Assist corporate management in the operation and maintenance of the ISO 13485 and FDA 21 cfr 820 compliant quality system

Requirements for the Quality Assurance Engineer

  • B.S. Degree in Engineering or Life Sciences along with minimum of 5 years experience in electro-mechanical medical device
  • A.S.Q. Certified Quality Engineer or Six-Sigma Black Belt
  • A working understanding of FDA Quality System Regulations, ISO 13485, EU directives, applicable standards and guidance documents
  • Demonstrated success in requirements tracing, risk management planning and execution ( including authoring risk management plan, leading dFMEA and pFMEA and risk management reports) test method development and validation, as well as verification and validation planning
  • Requires the ability to effectively communicate technical aspects with peers and customers both verbally and in writing & also requires a motivated individual that is able to work with minimal supervision


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