Lead Quality Assurance

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…