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Product Complaint Specialist

Employer
Perkin Elmer
Location
Hopkinton MA US
Closing date
Jun 13, 2017

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Sector
Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Summary: The Product Complaint Specialist is a technical position that is responsible for receiving, documenting and coordinating complaint investigations of products according to FDA and European requirements for medical device complaints handling. This position interfaces with the Manufacturing Engineering, Service, and Technical Support groups as well as Site Management to support the resolution of complaint issues and initiation of corrective or preventive actions related to customer complaints and complaint product returns. Duties and Responsibilities:
  • Establish and maintain product complaint files for all customer complaints, according to US and International regulatory and compliance requirements.
  • Review of all received product complaints to identify if a complaint is reportable under the Medical Device Reporting (MDR) requirements in the US or other international Vigilance system.
  • Coordination with complaint investigation personnel to understand root cause analysis in support of documentation to properly close the complaint.
  • Interact with other functional groups inside and outside the Quality department during complaint investigation and closure process.
  • Maintenance of all complaint procedures, files and records according to established procedures
  • Establish and maintain quality metrics for all product complaints, according to the direction of the Quality leadership.
  • Oversee and coordinate the medical device product recall process, including recall reporting in the US, EU and Canada.
  • Support the ongoing education/training of personnel involved in the complaint handling and investigation process.
  • Support Continuous Improvement initiatives related to complaint handling.
  • Perform other duties as assigned.

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