Kinova Inc.
Ensure product development compliance according to applicable documents (standards, directives, procedures, quality plan); Ensure the proper application of all procedures and standards required for the development and preparation of production ramp-up; Ensure product compliance with applicable standards and regulations, from the development of the certification plan to the final technical file, by supervising compliance assessments and monitoring external testing; Lead the product risk management process in accordance with ISO 14971, from plan development to final report writing, by conducting risk analysis activities (e.g.,HA, dFMECA, pFMECA); Actively participate in design reviews for manufacturing processes of products under development; Review and approve test plans and reports required for product verification and validation; Ensure proper man...
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Lead, Quality Assurance, Product Development
Description
MAIN RESPONSIBILITIES
Product Development Quality Management: