Complaint Investigator
12d ago

Job Description


  • Evaluate customer feedback and customer and internal data for possible complaints
  • Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint
  • Communicate with call centre reps and FSEs to gather more data on complaints as needed
  • Assist the Vigilance Reporting team in collecting the required data for the initial assessment of reportability as well as any request of information from Competent Authorities and Notified Body
  • Support the screening of complaints for reported serious injury / deaths and the assignment to investigators within 2 business days
  • Gather information required for review and closure of complaint record according to the complaint handling procedure
  • Assess if the Risk assessment is covering the hazard in the complaint
  • Complete all needed records in a timely and accurate manner
  • Support review of complaint records to warrant the quality of the complaint record
  • Escalate to the CHU manager when necessary to determine the action to drive timely and effective resolution of the complaint

  • No major non-compliance in applicable process / records
  • Non-product feedback closure timeliness
  • Complaint record compliance completeness and timely closure
  • Complaint closure performance

  • Complaint Management
  • Quality Management
  • Bachelor degree
  • 2 - 3 years of experience in similar kind of role from medical device industry or regulated industry
  • Understanding of Complaint investigation process, global medical device regulations requirements and standards such as 21 CFR Parts 803, 806, and 820 & ISO13485
  • Knowledge on ISO 14971 is preferable
  • Good Verbal and written communication skills
  • Analytical skills and focus on detail
  • Teamwork in and outside Q&R
  • Fluent in English (verbal and written)
  • Product Knowledge is preferred
  • Apply
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