Medical Device Complaint Specialist

4 weeks ago


Hyderabad, Telangana, India Medtronic Full time

Careers in Quality Assurance

We are seeking a highly skilled Quality Assurance Specialist - Device Vigilance to join our team at Medtronic.

As a Quality Assurance Specialist - Device Vigilance, you will be responsible for reviewing, evaluating, classifying, and performing follow-up activities on all product complaints related to the identity, quality, reliability, safety, and effectiveness of medical devices.

You will evaluate complaints to determine if they reasonably suggest a device may have or could have caused or contributed to a death or serious injury.

In addition, you will write investigation summaries based on technical product analysis information provided by the plant.

Key Responsibilities

  • Complete training of complaint handling
  • Evaluate incoming complaint information and maintain the record in the electronic database
  • Perform follow-up activities to obtain additional information
  • Determine reportability of complaints to Government Agencies
  • Identify and document appropriate complaint categories to assure trend accuracy within the complaint database
  • Write investigation summaries based on technical product analysis information provided

Requirements

  • Bachelor's degree; Engineering or Science degrees preferred
  • 4 to 8 years quality assurance or regulatory experience in medical or pharmaceutical industry
  • Computer literate with skills in Word, Excel, Access, PowerPoint, and database trending analysis
  • Strong typing skills and ability to write business documents with minimal supervision


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