Medical Device Complaint Specialist
2 weeks ago
Careers that Change Lives
As a Medical Device Complaint Specialist at Medtronic, you will play a critical role in ensuring the quality and safety of our medical devices. Your primary responsibility will be to review, evaluate, and classify product complaints related to the identity, quality, reliability, safety, and effectiveness of our devices.
A Day in the Life
You will work closely with cross-functional teams, including Technical Services, Manufacturing, R&D, and Quality Assurance, to investigate and resolve complaints. Your expertise will be essential in determining reportability to government agencies and ensuring compliance with FDA and international regulations.
Key Responsibilities
- Complete training on complaint handling and maintain records in electronic databases.
- Evaluate incoming complaint information and perform follow-up activities to obtain additional information.
- Use and maintain databases, provide analysis and trending data on complaints.
- Determine reportability of complaints to government agencies.
- Identify and document appropriate complaint categories to ensure trend accuracy.
- Write investigation summaries based on technical product analysis information.
- Ensure record documentation is maintained in a constant state of audit readiness.
Requirements
- Bachelor's degree in Engineering or Science (e.g., SW, EE, ME, Biomedical Engineering).
- 4-8 years of quality assurance or regulatory experience in the medical or pharmaceutical industry.
- Strong typing skills and ability to write business documents with minimal supervision.
- Strong verbal and written communication skills and ability to work in a team-oriented environment.
- Ability to multitask and understand the functionality/intended use of complex medical devices.
Nice to Haves
- Knowledge of medical devices, their development, and quality control.
- Knowledge of FDA, MEDDEV, and Canadian regulations.
- Technical writing experience.
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