Manager, Complaint Handling
Job TitleManager, Complaint Handling
Key Areas of Responsibility: • 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. Leads a team of complaint investigators to ensure thorough, high quality complaints investigations are being performed.
- Initiate complaint in process and applicable tool. Manages complaint handling unit metrics to ensure an efficient and optimized work flow.
- Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint Provides feedback to direct reports and responsible for the development of their team.
- Communicate with customers, call center reps and FSEs to gather more data on complaints as needed Escalates issues to other subsystem teams to insure timely processing of complaints.
- Confirm complaint condition and determine corrective action (including CAPA as needed) Support internal and external audits in both front room and back room roles.
- Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed Conducts CAPA investigations and drives actions through CAPA record closure.
- Assess if the Risk assessment is covering the hazard in the complaint
- Complete all needed records in a timely and accurate manner Works cross-functionally as needed to ensure customer satisfaction issues are appropriately handled, help drive product quality improvements and ensure a compliant process through following procedures, escalating issues and driving continuous improvement.
- Bachelor’s degree or equivalence work experience
- 3-5 years of related experience in a medical device or regulated industry.
- >3 years Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, ISO 9001.
- >5 years of related experience in a medical device or regulated industry.
- European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169
- Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
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