Quality Assurance Engineer

  • location: Mansfield, MA
  • type: Contract
  • salary: $38 - $40 per hour
easy apply

job description

Quality Assurance Engineer

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

    Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

    easy apply

    get jobs in your inbox.

    sign up

    related jobs

      Mobile QA Engineer

    • location: Brighton, MA
    • job type: Permanent
    • salary: $100,000 - $130,000 per year
    • date posted: 1/17/2020

      QA Engineer

    • location: Boston, MA
    • job type: Temp to Perm
    • salary: $27 - $45 per hour
    • date posted: 1/7/2020