Design Quality Engineer With Medical Device

2 months ago


North Haven, United States Grove Technical Resources, INC Full time

Title - Sr Quality Engineer - Exempt

Job Location - North Haven, Connecticut.

Duration: 12 months

Job Description

Responsibilities may include the following and other duties may be assigned.

  • The Senior Quality Engineer position on the team supports new product development for various product families in the Surgical Innovations Business.
  • In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team.
  • An understanding of Reliability Engineering combined with Defect/Issue Management, Reliability Test Method Development/Setup/Analysis, Reliability Demonstration Analysis, Develop/Conduct Reliability studies and evaluations, Mechanical and Electro-Mechanical Design, Design Failure Modes and Effects Analysis, Design Verification, Design Validation, process validation, Reliability (Planning, Allocation, Modeling, Prediction, Strategy, Assessment), Reliability Test Development, Electromagnetic Compatibility (EMC) Requirements/Testing/Development, Risk Management process per ISO 14971 is preferred.
  • As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality

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