Complaints Investigator # JN -012020-51012

Description:

• 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