Product Complaints Quality Assurance Lead
2 weeks ago
Medtronic
">Careers that Change Lives
">A leading role in product complaints quality assurance requires strong leadership and analytical skills.
">You will be responsible for providing strategic guidance to a team handling product complaints, evaluating strategies for continuous improvement, and maintaining accurate records in electronic databases.
">Job Responsibilities
">• Provide leadership to a team handling product complaints
• Evaluate strategies for transformation and continuous improvement
• Maintain accurate records of incoming complaint information in electronic databases
• Perform follow-up activities to obtain additional information and provide analysis and trending data on complaints
• Determine reportability of complaints to government agencies
• Identify and document appropriate complaint categories to ensure trend accuracy within the complaint database
• Write investigation summaries based on technical product analysis information provided
• Ensure record documentation is maintained in a constant state of audit readiness per internal policies
• Liaise with groups performing additional investigations and preparing written records of investigation
• Interact with Technical Service, Manufacturing, R&D, and Quality Assurance as needed during complaint processing
• Provide basic technical expertise and assistance in handling complaints to comply with current FDA and international reporting regulations
• Review and interpret risk management documentation as it applies to complaint events
• Interact with multiple departments within Medtronic, such as Technical Services, Failure Investigation, R&D, Manufacturing, and Engineering, as well as external groups like customers, vendors, and healthcare professionals.
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