Duration: : 6 months extendable
Client: Among Fortune 500
Location: San Diego, CA
Review and approve complaints to ensure that records meet clietns and regulatory requirements
• Responsible for 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.
• Receive initial complaint from any source (external and internal) and ensure all information/data is accurately captured at point of contact
• Maintain an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives.
• Review complaint data, assess for reportability and escalate to the safety teams for reportability assessment.
• Performs intake / follow up / data entry activities and attaches corresponding source documents in a timely manner per requirements and directives.
• Triage call from all sources for quality technical complaint, Adverse Event, request for refund, request for replacement product and request for credit.
• Reviews data entry and follow-up activities for completeness and timeliness
• Closes files according to established guidelines to meet required timelines
• Maintains a working knowledge of company policies and procedures, departmental processes, and associated procedures and work instructions ,Philips IGT devices for IFUs, Manuals, Promotional Material; coronary and therapeutic procedures
• Informs management of potential safety issues, emerging trends and/or concerns
This is a complaints coordinator position (not customer service rep II) for medical device products
• Bachelor's degree or equivalent years of directly related experience
• Minimum of 2-3 year directly related experience
• 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)
• Solid knowledge 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.