Philips Complaint Investigator in Pune, India

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KEY AREAS OF RESPONSIBILITIES:

  • 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

KEY PERFORMANCE INDICATORS:

  • No major non-compliance in applicable process/records

  • Non-product feedback closure timeliness

  • Complaint record compliance completeness and timely closure

  • Complaint closure performance

REQUIRED COMPETENCIES:

  • 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

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