Design Assurance Quality Engineer

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Design Assurance Quality Engineer

  • Specialty:

  • Title:

    Design Assurance Quality Engineer
    • City:

      Brooklyn Park
    • State:

    • Zip Code:

  • Start date:

  • Status:

  • Assignment Type:

    Direct Hire
  • Job Id:



The DAVIS Companies is seeking a Design Assurance Quality Engineer for a growing leader in the medical device industry. This is a key role with the organization providing support for new product development projects. 

Responsibilities of Design Quality Engineer: 

  • Manage deliverables from the design process including DHF and Engineering Project File documents
  • Collaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified
  • Participate on design teams to assure customer product requirements as well as quality requirements are documented and addressed. 
  • Collaborate with design engineers and technicians in the development of verification/validation protocols.
  • Participate on design teams in the performance of DFMEA, PFMEA and Risk Management activities
  • Assist with the development of inspection processes and equipment if and when required
  • Work with Manufacturing Engineering, Operations, Business Development, and Quality, during concept, prototyping, and transfer of new products into production.
  • Assure that design specifications are accurately translated into production/process specifications

Requirements of Design Assurance Quality Engineer: 

  • Bachelor’s Degree/Technical Degree in Engineering or equivalent experience
  • 5 – 10 years’ experience in a  Medical Device manufacturing/product development environment
  • Working knowledge of FDA QSR’s, ISO 13485, and ISO 14971 requirements
  • Experience/knowledge with product/process verifications/validations
  • Experience with DFMEA’s, PFMEA’s and Risk Management
  • Must possess good project management skills and initiative in taking on and completing projects
  • Must possess good verbal and written communication skills
  • Must be able to manage and prioritize multiple projects/objectives

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