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    Design Quality Engineer - Bridgeport, United States - CooperSurgical

    CooperSurgical
    CooperSurgical Bridgeport, United States

    3 weeks ago

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    Description
    CooperSurgical, Inc.

    seeks a Design Quality Engineer in Trumbull, CT, to support the development and delivery of Cooper products by providing technical engineering support to new products and sustaining engineering.

    Interface with manufacturing vendors to minimize potential problems throughout the product life cycle. Support supplier new tooling to ensure final components are qualified at the supplier utilizing PPAP tool. Ensure the delivery of the final product is within regulations and meets customer expectations. Develop master test plans to incorporate design verification and validation, and process validation activities. Review testing protocols and reports to ensure all testing adheres to regulatory requirements.

    Perform a quality review of nonconforming materials and products used in pilot and clinical builds to determine the best economical and feasible approach for disposing.

    Collaborate with cross-functional teams to remediate products and processes to ensure compliance with the European Union Medical Regulation (EU MDR).

    Remote work permitted 3 days per week.

    Requirements:

    Bachelor's degree in Engineering, or a related field, and 2 years of experience in Quality Engineering in the medical device industry.

    2 years of experience in engineering areas, e.g. R&D.

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