Quality Assurance Manager (Medical Products)
As Quality Assurance Manager, your main function will be to ensure the quality and conformity of the products-medical instruments manufactured by Kinova.
- Ensure maintenance of customer requirements and regulatory compliance of the product by evaluating design changes;
- Ensure 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 of the jig tests used in the product verification and validation plan and participate in the execution of the validation;
- Provide regulatory oversight and ensure product compliance to respond to regulatory changes;
- Evaluate risks across the product life cycle and keep the risk management plan up to date;
- Carry out after-sales monitoring of medical instruments;
- Conduct investigations to follow up on failures that occur internally and with customers, in conjunction with the procurement, production, and engineering teams, identify the causes and provide solutions;
- Manage and analyze data relating to different processes, product quality, and identify opportunities for improvement.
- Hold a university degree in engineering (robotics, electrical, software, mechanics, biomedical or similar);
- Minimum 5 years of experience in the field of quality and regulatory compliance;
- Experience with ISO 13485: 2016, FDA 21 CFR Part 820, MDR 2017/745 regulations;
- Experience in the surgical robotics industry (an asset);
- Skilled in time management and maintaining schedules in a fast-paced environment;
- Proven ability in analytical reasoning, problem-solving and critical thinking;
- Team spirit, influence, and communication;
- Confirmed leadership;
- Bilingual (English and French).
- As soon as possible
What we offer:
- Snacks, coffee, and fresh fruits at all time;
- 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;
- Competitive salaries;
- 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...