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PMS complaint Handling

3 months ago

Bengaluru, India HTC Global Services Full time

Exp- 4- 6 years


Location – Bangalore

Notice period – Immediate.

Description:

PMS and complaint handling, Medical Device Software domain

Mandatory Skill Required

"Knowledge in the area of Complaint handling and PMS for Medical products

Knowledge of Software product development"

Good to Have/Optional Skills

"Trackwise tool ", CAPA

Job Responsibilities

"Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally

Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint.

Initiate complaint in process and applicable tool.

Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint

Communicate with customers, call center reps and FSEs to gather more data on complaints as needed

Assess if the Risk assessment is covering the hazard in the complaint

Complete all needed records in a timely and accurate manner

Confirm complaint condition and determine corrective action (including CAPA as needed)

Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed

Evaluates, investigates, and resolves complaints

Completes initial assessment of reportability and escalates to manager to determine action, when necessary.

Analyzes complaint data, gathers additional data as needed, and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolves complaints."



Relevant candidate with strong exp can reach out to me over the mail chandni.kumari@htcinc.com