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

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

 

Responsibilities

  • 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
 


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