Complaint Handling Specialist I

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Complaint Handling Specialist I

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    Complaint Handling Specialist I
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Searching for a Complaint Handling Specialist in Milford, MA on a long term contract basis.

The Complaint Handling Specialist I position provides an exciting opportunity that will allow a successful candidate to develop within the quality organization. This position will work closely with other departments/groups to maintain compliance within the complaint handling process. He/she will help drive continuous improvement through CAPA, assisting project/continuous improvement activities and providing subject matter expertise on the complaint handling processes.


  • Manage and document thorough and accurate complaint records in the TrackWise system while ensuring they are processed in a uniform and timely manner
  • Ensure complaint records and applicable complaint handling documents are compliant with Good Documentation Practices (GDP)
  • Determine reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.
  • Work with the Field Service Organization and various Waters manufacturing facilities to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements both domestic and international
  • Collect, review, track, trend, analyze, and report of complaint data generated from the complaint handling system to create monthly and quarterly reports
  • Identify complaint trends and signals that can feed the CAPA process to drive continuous improvement for Waters medical devices and the Complaint Handling Process, as needed.
  • May assist in preparation of HHEs (Health Hazard Evaluations)
  • Support post market surveillance reporting activities, as needed.
  • Support specific project initiatives if needed


  • Bachelor’s degree, preferably in a life science (biochemistry, clinical chemistry) or related field of study or equivalent experience
  • Experience with Complaint Handling in the biotechnology, medical device or pharmaceutical industry preferred
  • Understanding of the domestic and international requirements for Complaint Handling, Medical Device Reporting, and Vigilance (QSRQSR, ISO 13485, ISO 9001 etc.) preferred
  • Analytical Aptitude and experience with statistical tools preferred.  
  • Excellent communication skills, both written and verbal.
  • Problem solving skills
  • Able to work well within a team
  • Highly organized with strong attention to detail
  • Self-motivated
  • Proficient in MS Word, Excel, and Power Point preferred
  • Ability to prioritize the workload and effective time management



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