View this new "Lead, Quality Assurance, Product Development" opening in Montréal, Canada. Apply for jobs in your niche area, and explore related local engineering / Quality Assurance - QA/QC jobs in Boisbriand Montréal and nearby county areas of Province de Québec Canada.
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).
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