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Quality Management Associate Location: US-MI-Delton Email this job to a friend
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Responsibilities: - 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.
Requirement: - 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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