Current Advertised Positions
Job Details

Quality Assurance Analyst
  • medical device
  • Health Canada/FDA
  • French/English proficiency

This position is a one year contract with the possibility of an extension.



  • Demonstrates thorough understanding of quality management standards and regulations as outlined in Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFR’s), Health Canada’s Medical Device Regulations and ISO 13485
  • Manages individual complaints on various medical device product lines, from opening to closing.
  • Performs accurate and timely data entry in a corporate complaint database
  • Reviews complaint investigation results to ensure adequate and thorough investigation strategies are followed
  • Communicates directly with Clients customers regarding reported complaints and resolutions
  • Makes decisions related to reportability of product complaints and prepares/submits reports to regulatory authorities in a timely manner
  • Responds to technical or medical information requests from healthcare professionals
  • Provides ad hoc reports related to product complaint trending and investigations


Required Qualifications

  • Bachelors of Science or equivalent in a Scientific, Technical or Engineering discipline
  • 0-2 years work experience, in the medical device industry or other Health Canada/FDA regulated industry
  • Bilingual (French/English)
  • Excellent communications skills (written, verbal)
  • Ability to learn quickly and keep abreast of changing regulatory requirements


Preferred Qualifications

  • Experience with complaint handling and adverse event reportability assessments in the medical device industry



Job Ref: CA787ERB000007
Submitted: 11-01-2019 03:08 PM
Location: Ontario - Markham and area

Job Search
Please make your selection and click 'Search'. If you know the job reference number, please enter it directly below.
(To multi select, use the control key)
By Keyword or Job Ref
By Location
By Area
By Category
By Employment Type
Privacy Statement