Quality Assurance Manager

Description:

Kinova, a leader in advanced robotics and assistive technologies, is seeking an experienced and detail-oriented Responsable Assurance Qualité – Maintien de Produits (Quality Assurance Manager – Product Maintenance) to oversee and manage the quality of existing products in production. This pivotal hybrid role combines process oversight, problem-solving, and compliance management with regulatory standards to ensure products maintain and improve their safety, performance, and customer satisfaction.

As the voice of quality for assigned product lines, the successful candidate will handle non-conformities, customer complaints, risk management, and the Engineering Change Order (ECO) process. This position requires strong collaboration across departments including engineering, production, customer service, and supply chain to ensure high-quality standards are consistently met.

Key Responsibilities:

Product Quality Management:

• Enforce quality procedures and standards throughout the product lifecycle — from material reception to distribution.

• Monitor product quality indicators (RMA, customer returns, production efficiency) and conduct trend analyses to drive continuous improvement.

• Lead risk management processes in compliance with ISO 14971, updating risk analysis files based on post-market surveillance and manufacturing changes.

• Evaluate ECO requests to uphold product safety, reliability, and regulatory compliance.

• Review and approve product verification and validation test plans and reports.

• Ensure products remain compliant with applicable certifications and regulatory frameworks throughout changes.

• Keep quality control plans up-to-date in response to changes or identified quality issues.

• Audit production lines and support internal/external audits.

• Validate deliverables (engineering drawings, work instructions, equipment qualifications) before product release under ECOs.

Complaint Management:

• Support complaint investigations in coordination with the After-Sales Service and Engineering Liaison teams.

• Collaborate with internal departments to investigate failures, determine root causes, and implement corrective actions.

• Lead resolution of major customer complaints for assigned products.

Non-Conformity Management:

• Ensure effective implementation and enforcement of production control plans.

• Verify that products and sub-assemblies meet specifications throughout manufacturing.

• Assess and support resolution of production deviations and non-conformities, including root cause analysis and CAPA (Corrective and Preventive Actions) development.

• Lead resolution of major production non-conformities.

Required Qualifications:

• Bachelor’s degree in Engineering.

• Minimum 5 years of relevant experience in quality assurance within a regulated environment.

• Licensed Engineer or Engineer-in-Training with Ordre des ingénieurs du Québec (OIQ).

• Six Sigma Green Belt or Black Belt certification is an asset.

• Familiarity with regulatory frameworks: ISO 13485:2016, FDA 21 CFR Part 820, MDR 2017/745 (preferred).

• Experience with product certification in the medical device industry is a strong asset.

• Excellent analytical thinking, problem-solving, and critical reasoning skills.

• Skilled at managing timelines and multitasking in fast-paced settings.

• Strong communication, team collaboration, and interpersonal influence.

• Bilingual proficiency in French and English is required.

Benefits:

• Hybrid work model

• Competitive salary

• Employer-contributed collective RRSP

• 50% company-paid group insurance

• Stable schedule with up to 4 weeks vacation

• Additional personal days off

• Free snacks, coffee, and fresh fruit at the office

• Supportive and passionate work culture

• Cutting-edge workplace environment

• On-site free parking and EV charging stations

• Regular social and sporting activities

• Inclusive company culture focused on employee development

• Commitment to diversity, equity, and accessibility