Kinova: Quality Engineer

SUMMARY OF THE FUNCTION As a Quality Engineer your main function will be to ensure the quality and conformity of the products-Medical Devices manufactured by Kinova.MAIN RESPONSIBILITIESDesign 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; Risk Managementand Regulatory Compliance; Provide regulatory oversight and ensure product compliance following regulatory changes; Assessing risksthroughout the product life cycle and keeping the risk management plan up to date; Perform post-market surveillance of medical devices; Quality Management and Improvement; Conduct investigations following failures that occur internally and at customers’ sites, in conjunction with the procurement, production and engineering teams, identify the causes and provide solutions; Manage and analyze data related to various processes and product quality and identify opportunities for improvement.JOB REQUIREMENTSHold a university degree in engineering (robotics, electrical, software, mechanical, biomedical or similar); Minimum 5 yearsexperience in the field of quality and regulatory compliance; Experience withISO 13485:2016, FDA 21 CFR Part 820, MDR 2017/745 regulations; Experience in the surgical robotics industry (an asset)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; Demonstrated leadership skills; Bilingual (English and French).