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Quality Engineer - Design

Company: DPS Group Global
Location: Auburn
Posted on: November 12, 2021

Job Description:

Position summary:DPS Group Global is seeking a Design Quality Engineer to support our medical device client in the Auburn, AL area. The Design Quality Engineer will be working with a New Product Introduction team to support Design and Development. (This opportunity is not remote and will be full-time at the client site) Key responsibilities:

  • Updating the User requirements based on market/field applications feedback for new product (not a line extension).
  • Generating the Design input based on #1 and subsequently support the creation of Design Outputs (working with Engineering, Quality, Production).
  • Evaluate Risk Management (per ISO 14971) on product risks - align with #4 and process Risk.
  • Overseeing the Design Test Matrix (Verification and Validation) - generate protocols for V&V.
  • Attend Design Reviews and provide input.
  • Build Design History File based on 1-5.
  • Coach / mentor other team members in the use of Design controls where appropriate. Education & experience:
    • Bachelor's degree in engineering, equivalent degree, or extensive work experience.
    • The individual has to be able to provide real-world application experience and examples rather than identify a procedure for others to review and "figure it out".
    • Plastics background would be helpful.
    • Familiar with and understand recognized regulations and standards such as (where applicable): 21 CFR Part 820 (FDA QSR, cGMP), ISO 13485 Medical Devices - Quality Management Systems, ISO 14971 Risk Management, ISO 9001 Quality Management Systems (preferred). The CompanyDPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up. DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.

Keywords: DPS Group Global, Auburn , Quality Engineer - Design, Engineering , Auburn, Alabama

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