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Randstad Quality Engineer in Mansfield, Massachusetts

Quality Engineer

job details:

  • location:Mansfield, MA

  • salary:$36 - $42 per hour

  • date posted:Monday, April 5, 2021

  • job type:Temp to Perm

  • industry:Manufacturing

  • reference:831927

job description

Quality Engineer

job summary:

Quality Assurance Engineer needed for immediate contract to direct opportunity in the Mansfield, MA area. This person will work with team to establish, improve and maintain a corporate quality system, and to provide quality assurance support to medical device development and validation efforts. Along with management and engineering staff, the Quality Assurance Engineer will be responsible for various aspects of implementing and maintaining ISO 13485 and FDA GMP quality system procedures. This person will also participate in product development teams to provide design control quality assurance functions. Apply now for immediate consideration!

location: Mansfield, Massachusetts

job type: Contract

salary: $36 - 42 per hour

work hours: 8am to 4pm

education: Bachelors

responsibilities:

  • Participate in the technical review of design input specifications and design documentation for new medical devices

  • Represent Quality Assurance on new product and improvement teams by qualifying new suppliers, communicating quality/compliance requirements, developing SOP's, approving specifications and providing technical transfer/validation support.

  • Plan, develop and execute verification and validating testing for products under development

  • Manage and monitor CAPA and NCMR system performance to drive timely resolution and continuous improvement

  • Perform internal quality and design control audits

  • Develop and/or contribute to the Risk Management Plan, Verification & Validation Plan, Quality Plan, Product Development Plan or other design control efforts as directed by the Project Manager

  • Assist corporate management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements

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qualifications:

  • Experience level: Experienced

  • Minimum 5 years of experience

  • Education: Bachelors (required)

skills:

  • Medical Device Engineering

  • BSME

  • ASQ certification

  • Six Sigma

  • Requirements

  • Design Assurance

  • CAPA and NCMR

  • V and V Testing

  • FDA ISO 13485 Experience

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.

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