Complaint Investigator (NCS/Job/ 2513)
Job Skills
Job Description
Function: Complaint Handling
Role: Complaint Investigator
As a complaint investigator, the candidate will be responsible for the below activities:
1) Review and understand complaints received from market. Analyse the complaint from all the aspects to initiate investigation.
2) Review and understand various clinical/non-clinical adverse events that may be associated with the complaints.
3) Assess various literature publications and handle complaints generated out of those.
4) Inspect and investigate medical devices from a visual, functional and dimensional standpoint. The candidate must be well verse with engineering drawing and design.
5) Review risk management file and assess risk concerning a complaint from the market.
6) Review NC and CAPA and be able to identify any occurrence of an NC.
7) Draft conclusion of the overall investigation performed in a precise manner, covering all the aspects and clearly presenting the root cause.
8) Good command over written and spoken English.
9) Contribute in overall process improvement activities.
Basic Desirable Skillset: Root cause analysis (Why-why analysis, cause & effect etc), NC, CAPA, Knowledge on ISO13485, Risk management, Basic mechanical concepts, engineering drawing.
Desirable Educational Background:
B. Tech / M.Tech Mechanical with 2-3 years of work experience
