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Development Quality Engineer - Locals Need W2role
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- Role: Development Quality Engineer II
- participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables, support on-time execution ofQuality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects, accountable for generation of PDP design verification test plans/reports for product/system requirements.
- lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments, lead identification of essential outputs and generate Essential Output reports,
- work with design engineering in the completion of customer/system/product requirements
- work with design engineering in the completion of product verification and validation, endure DHF content completion, integrity and regulatory & standards compliance, collaborative communication resolving gaps, complete document change request reviews in a timely and objective manner
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