Complaints Investigator # JN -012020-51012

Andover, Massachusetts
Industry: Business Analyst / Project Manager
Job Number: JN -012020-51012


  • This is a Complaints Investigator position for IGT Devices; part of the Image Guided Therapy business group. In this role, you have the opportunity to work with cutting-edge medical device product lines

Responsible for any of the following:

  • Day-to-day complaint management of quality, technical and adverse event complaint records, including intake, follow up, triage and entry, in accordance with local and international regulations, guidelines, and applicable directives
  • Receipt of initial complaint from any source (external and internal) and ensuring all information/data is accurately captured at point of contact. You may triage calls from various sources for complaints, request for refund, request for replacement product and request for credit
  • Maintaining an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives
  • Reviewing complaint data, assessing against reporting requirements and escalating for additional potential safety evaluation. May compose and/or submit Medical Device Reports
  • Performing intake / follow up / data entry activities and attaching corresponding source documents in a timely manner in a high volume, fast paced setting per requirements and directives
  • Reviewing record documentation and follow-up activities for completeness and timeliness
  • Closing files according to established guidelines to meet required timelines
  • Maintaining a working knowledge of company policies and procedures, departmental processes, and associated procedures and work instructions, IGT devices for IFUs, Manuals, Promotional Material; coronary and therapeutic procedures
  • Informing management of potential safety issues, emerging trends and/or concerns

Skills and Experience:

  • Bachelor's Degree
  • Prior complaint handling experience in a medical device industry
  • Knowledge of FDA/QSR requirement & quality systems in Pharma and/or Medical device experience required (i.e. 21 CFR Part 820, Quality System Regulations, 21 CFR Part 803, Medical Device Reporting, The Privacy Rule, HIPAA, ISO 13485)
  • Demonstrated experience meeting performance requirements
  • Solid experience with use of word processing, spreadsheet, database and presentation applications
  • Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members
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