PMS and Complaint Analyst

About the Role:

We are looking for a PMS and Complaint Analyst with 4 to 6 years of experience in Complaint handling and PMS for Medical products.

Requirements:

• Understanding of ISO13485, ISO14971, ISO 62304 (Plus), MDR, EUMDR requirements is a plus.
• Comprehension of Software product development lifecycle.
• Hands-on with complaint management tools such as track wise is a plus.
• Succeed with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service and Application Engineers and Manufacturing personnel to facilitate the complaint handling process globally.
• Evaluating customer feedback, service records, and other sources of customer and internal for possible complaint.
• Initiating complaint in process and applicable tool.
• Estimating incoming data and determine if it is sufficient to understand the nature of the complaint.
• Communicating with customers, call center reps and FSEs to gather more data on complaints as needed.
• Assessing if the Risk assessment is covering the hazard in the complaint.
• Completing all needed records in a timely and accurate manner.
• Confirming complaint condition and determine corrective action including CAPA as needed.
• Corresponding with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed.
• Familiarity with evaluates, investigates and resolves complaints.
• Completing initial assessment of reportability and escalates to manager to determine action when necessary.
• Analyzing 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.