Manager, Complaint Handling

Job TitleManager, Complaint Handling

Job Description

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.

Minimum Qualifications:

  • 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.

Desired Qualifications:

  • >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

Skills:

  • 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.

Contact

In case of difficulties with your job application please send an email to [email protected]


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