PMS and Complaint Analyst

Job Description

About The Role We are seeking a PMS and Complaint Analyst with 4 to 6 years of expertise in ISO13485, ISO14971, ISO 62304 (Plus) MDR and EUMDR requirements will be a plus. Requirements Experience in Complaint handling and PMS for Medical products. In-depth knowledge of Software product development lifecycle. Hands on with complaint management tools such as track wise Is plus. 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. Evaluate, investigate and resolve complaints. Completes the 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. Show more Show less