Medical Device QA Specialist - Toronto, Ontario Canada - 33419



JOB DESCRIPTION

Job #: 33419
Title: Medical Device QA Specialist
Job Location: Toronto, Ontario - Canada
Employment Type:
Salary: contact recruiter for details
Other Compensation: benefits
Employer Will Recruit From: Local
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Great opportuonity with growing medical device company -

Joining a small, focused essential team -

Rewarding work related to life-saving devices

JOB DESCRIPTION

Entrepreneurial Mississauga medical device company with successful surgical products on the market is looking fora Senior Medical Device QA Specialist. You will be involved in the successful running of a Quality Management System, presently paper based, covering all aspects of product quality and regulatory compliance (Health Canada and EU Medical Devices), non-conformities, ISO 13485, and any agency actions.

Products are Class III Medical Devices.

ROLE AND RESPONSIBILITIES:

  • Part of the team running the QMS.
  • Ensuring that products meet quality requirements - Canada, EU (MDD), ISO.
  • Help with all quality / regulatory audits, and inspections.
  • CAPA, post-market surveillance,liaising with clients, operations, sales and marketing as necessary.
  • Helping provide excellent business solutions for manufacturing and process improvement.
  • Taking part in product production and release.
  • Help with MDR/vigilance reporting, document control, microbiology, product release functions.

 

QUALIFICATIONS

REQUIREMENTS:

  • BS Biology, Biomedical Engineering, related.
  • Experience running Quality Management Systems.
  • Quality Management metrics.
  • Experience with ISO 13485, audits, compliance.
  • History working with Class III and or IV Medical Devices very helpful.
  • Able to work alone or in a team.
  • Any certifications - e.g. ASQ / CQA / CBA or ISO 13485.
  • Any project management experience of interest.

Education:
University - Bachelor's Degree/3-4 Year Degree

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