Specialist Quality Assurance, Engineeri

2 days ago

Boisbriand, Canada Kinova Full time

"Ensure product compliance with applicable standards and regulations while participating in the quality improvement of current and future products."

Reporting to the Team Leader - Quality Assurance Engineering within the Engineering and Program Department, you will collaborate with the various product development teams as well as other departments at Kinova to ensure product compliance with applicable standards and regulations while participating in the quality improvement of current and future products.

**MAIN RESPONSIBILITIES**:
Product certification and regulatory compliance:

- Develop a certification plan and other associated deliverables according to the product and target market;
- Review and approve test and validation methods related to product certification;
- Review and approve the results reports related to the product certification;
- Participate in defining the validation requirements for the jig tests used in the product verification and validation plan and participate in the execution of the validation;
- Ensure regulatory oversight and product compliance following regulatory and standards changes;
- Evaluate change requests and their impact on product certification.

Risk Management:

- Prepare risk analysis documents in collaboration with the engineering team (Risk Management File, DFMECA, PFMECA, etc);
- Lead risk identification and mitigation activities during the development and life cycle of the product;
- Evaluate change requests and their impact on product safety.

Complaint management:

- Manage complaints in collaboration with the after-sales service group and the quality compliance team (cause analysis, corrective action plan, etc.);
- Investigate internal and customer failures in conjunction with the procurement, production and engineering teams, identify the causes and provide solutions;
- Evaluate the risks of deficiencies and keep the risk management plan up to date;
- Analyze complaint analysis data and propose solutions to improve the quality and reliability of our products.

Continuous Improvement:

- Manage and analyze data related to the various processes, product quality and identify opportunities for improvement;
- Introduce new practices for the development and improvement of existing products;
- Participate in the updating of procedures and various continuous improvement projects using best practices in change management.

POSITION REQUIREMENTS
- University degree in engineering;
- Minimum of 5 years of relevant experience in quality assurance (design) or product certification;
- Engineer in good standing with OIQ or CPI
- Knowledge of ISO 13485:2016, FDA 21 CFR Part 820, MDR 2017/745 regulations (asset),
- Knowledge of product certification to CE Mark, CSA/UL, FCC, ISO/IEC, RoHS/REACH such as IEC 60601, IEC 61000 Series, IEC 60204-1, ISO 13849, ISO 10218, and ISO 15066, etc (asset)
- Skilled in time management and maintaining schedules in a fast-paced environment;
- Proven analytical reasoning, problem solving and critical thinking skills;
- Team player, influencer, educator and communicator;
- Bilingual (English and French).

WHAT WE OFFER
- Hybrid teleworking;
- Competitive salaries;
- Group RRSP with employer contribution;
- Group insurance paid at 50% by Kinova;
- Stable schedule;
- 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...

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