Quality Engineer I, Design Assurance

11 hours ago


Mississauga, Canada Boston Scientific Full time

About the role:Our team is growing, and we are currently looking for a Quality Engineer I, Design Assurance to join our Quality team. This position works closely with New Product Development teams to ensure risk management is applied and to ensure adequacy design controls as well as production and process controls. Our team also works to enhance quality as a whole through design quality assurance and compliance improvement projects. Your responsibilities will include: Working within a team to identify and implement effective controls to support development and maintenance of products to meet internal and external requirements Developing understanding of Design Controls, Risk Management and Usability for Medical Devices Applying repeatable problem-solving concepts Keeping abreast of standard practices Supporting departmental, functional, and divisional design quality goals and priorities. Building quality into all aspects of work by maintaining compliance to all quality requirements Participating in various design quality assurance and compliance improvement projects Other duties as necessary or required by the organization Required qualifications:  Bachelor’s degree in Biomedical Engineering, Mechanical, Electrical Engineering or related field of study 1+ year of related work experience from Medical Device Industry Demonstrated interpersonal skills with ability to work within a team environment Strong written/verbal communication skills Ability to travel (less than 25%) Preferred qualifications:  Six Sigma problem solving methodologies Knowledge of ISO 13485, ISO 14971, IEC 60601 Medical imaging experience



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