Lead Quality Assurance-(Product Development- AARP), intermediate Jobs in Boisbriand, Canada at Kinova Inc.
Location: Boisbriand
MAIN RESPONSIBILITIES
Quality Managementin Product Development:
Ensure the conformity of product development according to the applicable documents (standards, directives, procedures, quality plan);
Adapt the quality requirement level and the application of procedures according to the product classification (e.g., rigor of IEC 60601-1-11 for medical assistance products vs. agility for research/professional products);
Ensure the proper application of all procedures and standards necessary for the development and preparation for production of products;
Ensure product conformity with applicable standards and regulations, from the development of the certification plan to the final technical file, by overseeing conformity assessments and external testing follow-up;
Lead the product risk management process in accordance with ISO 14971 (or relevant industrial standards), from the plan development to the final report writing, by conducting risk analysis activities (e.g., HA, dFMECA, pFMECA);
Actively participate in design reviews of manufacturing processes for products under development;
Review and approve the test plans and reports necessary for product verification and validation;
Ensure the proper management of product technical documentation (DHF, engineering drawings, work instructions, etc.);
Ensure the maintenance of product quality and conformity during design changes in development;
Evaluate the conformity of deliverables during the production transfer review and attest that the quality criteria are met for the transfer;
Collaborate with the sustaining quality assurance team to ensure an effective and complete transfer of quality requirements to production;
Participate in the updating and continuous improvement of development procedures using good change management practices;
Train and support the technical team on best quality and normative practices.
JOB REQUIREMENTS
Hold a university degree in engineering;
Minimum of 3 years of relevant experience in quality assurance (design) or product certification in a high-reliability field (e.g., Medical, Aerospace, Transportation, etc.);
Engineer in good standing with the OIQ or CPI;
Demonstrated leadership and ability to train/mentor a technical team;
Knowledge of regulations ISO 13485:2016, ISO 14971, FDA 21 CFR Part 820, MDR 2017/745 (asset);
Knowledge of product certification in accordance with CE Mark, 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. (asset);
Skilled in time management and maintaining schedules in a fast-paced environment;
Confirmed aptitude for analytical reasoning, problem-solving, and critical thinking;
Team spirit, influence, pedagogy, and communication;
WHAT WE OFFER
Personal days off in addition to vacation;
Snacks, coffee, and fresh fruit at all times;
A company culture focused on the development of each individual;
And much more, but you’ll have to meet us to learn more…
Title: Lead Quality Assurance-(Product Development- AARP), intermediate
Company: Kinova Inc.
Location: Boisbriand, Canada
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