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 Job #02372 Email this job to a friend
About our client
Our client is a medical device manufacturing company located in downtown Toronto, focused on the development and marketing of innovative methods of detecting breast cancer.
Position Location
Quality Engineer Toronto, ON
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Support the ongoing development of the company’s products
2) Provide Quality Engineering and Quality Assurance input
3) Oversee R&D and Manufacturing
4) Contribute in the effective implementation of a quality system to meet international regulatory requirements and standards
Requirements
1) B. Sc./M. Sc. in technical or biomedical field
2) Minimum 5 years of management experience within the medical device industry
3) 5+ years of experience in a quality discipline
4) Certified Quality Engineer and/or Certified Quality Auditor an asset
5) Experience with disposable development, testing and manufacturing would be a plus
6) Project management highly desirable
7) Experience in leading the quality assurance function in a medical device manufacturing environment including implementation of quality controls, validation techniques, and testing processes
8) Experience in implementation and maintenance of quality systems and functions in small company environment in a regulated field (preferably medical devices or biotech)
9) Able to demonstrate a thorough understanding of quality engineering tools & systems in the areas of design control, design, device and process validation in support of manufacturing and development of software controlled electrical equipment
10) Experience of working with electrical component, electrical device, and software design and development
11) Experience in implementing software quality assurance functions throughout the entire software lifecycle
12) Experience in working with electrical medical devices, both with hardware and software components

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