Medical Device Complaint Analyst

2 weeks ago

Salt Lake, Utah, United States Zobility Full time

Location: Salt Lake City, UT

Position: Contract

Type: Hybrid

Title: Medical Device Complaint Analyst (FDA)

Job Description:

  • The Complaint Analysts is responsible for processing complaint data and approving data entry and analyzing customer complaint information for the organization.
  • Customer Service receives the calls and collects information from customers.
  • Complaint Analysts review complaint information and work with various departments, including Customer Service, Clinical, Regulatory, and Service, to ensure the complaint records are complete, accurate and compliant with Quality Systems Work Instructions.

Responsibilities:

  • Handle complaint processing escalations in a consistent and timely manner
  • Reporting of Complaint Metrics to functional areas within MMD
  • Keep complaint handling work instructions up to date and in alignment with all Quality and Regulatory requirements
  • Maintain and provide standardized complaint data upon request
  • Maintain the standard for accurate record documentation of communication and correspondence with customers
  • Identify opportunities for improvements in complaint handling and provide training support as needed
  • Complaint triage and routing of complaint information to appropriate personnel
  • Ensure the complete and accurate documentation of complaints
  • Assist internal personnel on complaint investigations
  • Quickly identify and evaluate problems to reach a solution
  • Communicate answers and solutions to coworkers confidently
  • Assist other quality staff with their duties as requested
  • Maintain healthy and open communication lines with other departments
  • Complete required training in a timely manner

Required Qualifications:

  • Ability to solve complex problems under pressure
  • Strong file handling and organizational skills
  • Can maintain a professional manner while dealing with customer complaints.
  • Understanding or working knowledge of FDA complaint reporting per 21 CFR 803, preferred
  • Self-starter, able to manage a variety of tasks simultaneously, and lead others by example
  • Excellent analytical and communication skills
  • Ability to effectively communicate via email/telephone
  • Strong computer skills including Word, PowerPoint and Excel
  • Able to succeed in highly regulated compliance-oriented environment while still providing service excellence
  • Strong understanding of the FDA regulated products and services MMD offers
  • Strong grasp of company policies and able to make good decisions

Education and/or Experience:

  • Associate's degree (A.A.) or equivalent from two-year College or technical school; or four years related experience and/or training; or equivalent combination of education and experience.
  • One to two years of experience with customer complaints, Customer Escalations in an FDA regulated medical device company.

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