MDR/Vigilance Specialist II
3 days ago
Careers that Change Lives
Job Summary
We are seeking a highly skilled and detail-oriented Device Safety Specialist to join our team at Medtronic. As a key member of our quality assurance team, you will play a critical role in ensuring the safety and effectiveness of our medical devices.
Key Responsibilities
- Evaluate and classify product complaints related to the identity, quality, reliability, safety, and effectiveness of medical devices.
- Determine the reportability of complaints to government agencies and ensure compliance with FDA and international regulations.
- Write investigation summaries based on technical product analysis information provided by the plant.
- Liaise with internal departments, including Technical Services, Manufacturing, R&D, and Quality Assurance, to ensure timely and accurate complaint resolution.
- Provide basic technical expertise and assistance in handling complaints to comply with current regulations.
Requirements
- Bachelor's degree in Engineering or Science (e.g. SW, EE, ME, Biomedical Engineering) preferred.
- 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.
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