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    Senior Design Assurance Engineer - Minneapolis, United States - Cypress HCM

    Cypress HCM
    Cypress HCM Minneapolis, United States

    3 weeks ago

    Cypress HCM background
    Human Resources
    Description

    This Quality Design Assurance Engineer role will focus on design assurance supporting product and process development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality initiatives. This position interacts closely with the Engineering team as well as Operations, Quality Systems, Quality Assurance, Marketing, and Regulatory. This position is responsible for complying with the Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

    Responsibilities:

    • Execute and support completion of product and process development tasks.
    • Create and ensure completeness, accuracy, and compliance of DHF and DMR.
    • Support development and maintenance of customer requirements, product specifications.
    • Collaborate cross-functionally to lead and support completion and maintenance of product risk management tasks.
    • Author design verification and validation plan and report documents.
    • Support development of manufacturing processes, equipment, and product inspection documentation.
    • Author process validation plan and report documents.
    • Implement appropriate sampling inspection and support qualification activities for purchased components.
    • Support design and process test and inspection method development, and lead method validation activities.
    • Utilize statistical techniques to lead and support characterization, verification, validation testing, and root cause analysis.
    • Lead and support completion of risk management tasks to establish and maintain safe and effective products and processes.
    • Support quality system-related tasks including nonconformances and CAPAs.

    Requirements:

    • Bachelor of Science in Engineering
    • Strong experience with Quality in the medical device industry.
    • Must be able to work independently under limited supervision.
    • Advanced knowledge of basic Quality Systems and good documentation practices.
    • Experience in Non-Conforming Material Reporting
    • Experience in investigating and implementing Corrective and Preventive Actions
    • Experience in design controls, and test method and process validation
    • Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO
    • Strong communication skills, both verbal and written.
    • Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.
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