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 certication plan to the nal technical le, by supervising compliance assessments and monitoring external testing; Lead the product risk management process in accordance with ISO 14971, from plan development to nal 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 verication 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 efcient 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 certication; Member in valuable standing of the OIQ (Ordre des ingnieurs du Qubec) or Junior Engineer (CPI); Knowledge of ISO 13485:2016, ISO 14971, FDA 21 CFR Part 820, MDR 2017/745 (an asset); Knowledge of product certication 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 inuence, teaching, and communication skills; Bilingual (English and French). INCLUSION AND DIVERSITY

📌 Lead, Quality Assurance, Product Development (Boisbriand)
🏢 Kinova
📍 Boisbriand