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Kinova Inc.
Lead, Quality Assurance, Product DevelopmentKinova Inc. • Boisbriand
Lead, Quality Assurance, Product Development

Lead, Quality Assurance, Product Development

Kinova Inc. • Boisbriand
30+ days ago
Job type
  • Permanent
Job description

MAIN RESPONSIBILITIES

Product Development Quality Management:

  • 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 management of technical product documentation (DHF, engineering drawings, work instructions, etc.);
  • Maintain product quality and compliance during design changes during the development phase;
  • Evaluate the compliance of deliverables during the production transfer review and certify that quality criteria are met for the transfer;
  • Collaborate with the Sustaining Quality Assurance team to ensure an efficient and complete transfer of quality requirements to production;
  • Participate in the update and continuous improvement of development procedures using change management best practices.

JOB REQUIREMENTS

  • University degree in Engineering;
  • Minimum of 3 years of relevant experience in Quality Assurance (Design) or product certification;
  • Member in good standing of the OIQ (Ordre des ingénieurs du Québec) or Junior Engineer (CPI);
  • Knowledge of ISO 13485:2016, ISO 14971, FDA 21 CFR Part 820, MDR 2017/745 (an asset);
  • Knowledge of product certification in accordance with CE marking, CSA/UL, FCC, ISO/IEC, RoHS/REACH such as IEC 60601, IEC 61000 Series, IEC 60204-1, ISO 13849, ISO 10218, IEC 61508, and ISO 15066, etc. (an asset);
  • Skilled in time management and maintaining schedules in a fast-paced environment;
  • Proven ability for analytical reasoning, problem-solving, and critical thinking;
  • Team player with strong influence, teaching, and communication skills;
  • Bilingual (English and French).

INCLUSION AND DIVERSITY

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Lead, Quality Assurance, Product Development • Boisbriand

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