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Quality Management Associate
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  • Product Quality Complaints - Responsible for managing, processing, and executing customer complaints from system entry to closure.
  • Collaborate with global complaints network on overall complaints handling process including system improvements, process efficiency, and reporting.
  • Evaluate customer complaints for reportability to Health Canada.
  • Prepare Mandatory Problem Reports for submission to Health Canada.
  • Assess and report worldwide vigilance reports as required.
  • Prepare and communicate investigation results to customer.
  • Collaborate closely with internal customers including marketing and field associates.
  • Respond to Health Canada enquiries.
  • Process returned complaint samples and send replacement product to customer.
  • Utilize metrics and reporting to optimally supervise processes, drive improvement, and perform investigations as required.
  • Maintain complaint management procedures in alignment with corporate policies and procedures and Health Canada requirements, and provide training to impacted associates.
  • Ensure non-conformances are appropriately handled, and root causes are identified and effectively addressed to prevent recurrence.
  • Participate in internal and external audits, provide reports and documentation, close actions.


  • Bachelor of Science degree in life sciences or related field required.2-3 years quality experience in medical device and/or pharmaceutical industry.
  • Experience in complaint handling activities preferred.
  • Experience in SAP or TrackWise environment preferred.
  • Knowledge and experience with Good Manufacturing Practices and Canadian Medical Devices Regulations.

Katalyst HealthCares & Life Sciences Inc

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