Quality assurance engineer, medical products
As a quality assurance engineer, your main function will be to ensure the quality and conformity of the products (medical devices) manufactured by Kinova.
Main responsibilities - Design change management
- Ensures that customer requirements are maintained and that product regulatory compliance is maintained through the evaluation of design changes;
- Ensure that products are evaluated and tested for compliance with all applicable codes and standards (CE, CSA, FCC, ISO, UL, etc.) and that all safety and regulatory issues have been reviewed and approved;
- 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.
Main responsibilities - Risk management and regulatory compliance
- Provide regulatory oversight and ensure product compliance following regulatory changes;
- Assessing risks throughout the product life cycle and keeping the risk management plan up to date;
- Perform post-market surveillance of medical devices.
Main responsibilities - Quality management and improvement
- Coordinate investigations following failures that occur internally and at customers' sites, supporting the procurement, production, and engineering teams in identifying root causes and solutions;
- Manage and analyze data related to various processes and product quality and identify opportunities for improvement.
- Hold a university degree in biomedical engineering;
- Two to four years of relevant experience;
- Knowledge of ISO 13485:2016, FDA 21 CFR Part 820, MDR 2017/745 regulations;
- Ability to manage time and maintain schedules in a fast-paced environment;
- Demonstrated analytical thinking, problem-solving, and critical thinking skills;
- Team player, influential and communicative;
- Bilingual (English and French).
- As soon as possible
What we offer
- Snacks, coffee, and fresh fruits at all times;
- Devoted and formidable work team;
- Cutting edge technology work environment;
- Company culture focused on the active development of each individual;
- Personal days offs, in addition to vacation;
- Group insurance;
- Free parking;
- Charging stations for electric vehicles;
- Regular social and sports activities;
- And even more! But you'll want to meet us to know further...
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. Please note that access to our interview rooms and our office spaces already meet universal accessibility standards. For more information about our Diversity and Inclusion Policy or for any interview accommodation requests, please contact email@example.com or Dominique Brunet at (514) 277-3777 ext. 6.