Lead Quality Assurance

Permanent# Lead Quality Assurance Boisbriand Share As  a Quality Assurance Manager (Product Sustaining), you'll be actively involved with products currently in production, with an emphasis on non-conformance management, complaint handling, identifying product quality improvements, and participating in Engineering Change Order (ECO) cycles. The Product Sustaining Quality Assurance Manager is the voice of quality for their assigned product lines. The objective is to ensure the product maintains or improves its safety, reliability, performance, and compliance aspects while adhering to quality system requirements to meet customer satisfaction.
** MAIN RESPONSIBILITIES
**** Existing Product Quality Management
*** Ensure the proper application of all current procedures and standards to guarantee continuous product quality system conformity, from raw material reception and manufacturing to market distribution;
* Monitor and analyze quality performance indicators for existing products (RMA, customer returns, production efficiency) and conduct trend analyses to support continuous improvement for assigned products;
* Lead the product risk management process and maintain updated risk analysis files in accordance with ISO 14971 in response to post-market or production data, or following design or manufacturing process change requests;
* Actively participate in the evaluation of modification requests (ECOs) to ensure product quality, safety, reliability, performance, or conformity;
* Review and approve test plans and reports necessary for product verification and validation during change requests (ECOs);
* Ensure continued product conformity to applicable standards, certifications, and regulations during change requests (ECOs);
* Maintain quality control plans based on change requests (ECOs) or quality issues;
* Ensure the conformity of deliverables during change requests (ECOs) and certify that quality criteria are met for release (e.g., engineering drawings, work instructions, manufacturing process validation, equipment qualification);
* Perform audits of assigned production lines and actively participate in internal or external audits.
** Complaint Management
*** Support complaint management in collaboration with the after-sales service (repair) group and the engineering/liaison team (root cause analysis, corrective action plans, etc.);
* Support investigations following internal and customer failures, jointly with the procurement, production, and engineering/liaison teams, identify root causes, and implement solutions;
* Lead the resolution of major complaints for assigned products.
** Non-Conformity Management
*** Ensure the implementation and adherence to the production control plan;
* Ensure that products and sub-assemblies comply with their specifications and performance during the manufacturing process;
* Support the evaluation of production deviations/non-conformities, participate in root cause analysis, and develop CAPAs in collaboration with relevant stakeholders (production, manufacturing, engineering, after-sales service, etc.);
* Lead the resolution of major production non-conformities for assigned products.
** POSITION REQUIREMENTS
*** University degree in Engineering;
* Minimum of 5 years of relevant experience in quality assurance within a highly regulated environment;
* Licensed Engineer with the OIQ (Ordre des ingénieurs du Québec) or CPI (Candidate for the Engineering Profession);
* Six Sigma Green Belt or Six Sigma Black Belt certification (asset);
* Knowledge of ISO 13485:2016, FDA 21 CFR Part 820, MDR 2017/745 regulations (asset);
* Product certification experience in the medical field or other domains (asset);
* Skilled in time management and maintaining schedules in a fast-paced environment;
* Proven ability in analytical reasoning, problem-solving, and critical thinking;
* Team player with strong influencing, teaching, and communication skills;
* Bilingual (English and French).
** WHAT WE OFFER
*** Remote work (according to job type);
* Competitive salaries;
* Group RRSP with employer contribution;
* Group insurance paid at 50% by Kinova;
* Up to 4 weeks of vacation;
* Personal days off in addition to vacation;
* Snacks, coffee, and fresh fruit at all times;
* A dedicated and great work team;
* A state-of-the-art environment;
* A company culture focused on the development of each individual;
* Free parking;
* Electric vehicle charging stations;
* Regular social and sporting events;
* And much more, but you'll have to meet us to learn more…Kinova is committed to promoting a diverse and inclusive work environment for all and acting in discrimination against people on the basis of gender, nationality, minority status, or disability. As such, Kinova provides accommodation at all stages of the recruitment process and will treat all information relating to your health in a confidential and without prejudice.

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