Complaints Investigator

Duration:   3 months + contract with potentail to extend
Location:    San Diego, CA

Prior complaint handling experience in a medical device industry
o 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) 
o Solid knowledge of word processing, spreadsheet, database and presentation applications 
o Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members. 


As a part of our team, you may be responsible for any of the following: 
o 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. 
o 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. 
o Maintaining an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives. 
o Reviewing complaint data, assessing against reporting requirements and escalating for additional potential safety evaluation. May compose and/or submit Medical Device Reports. 
o Performing intake / follow up / data entry activities and attaching corresponding source documents in a timely manner per requirements and directives. 
o Reviewing record documentation and follow-up activities for completeness and timeliness. 
o Closing files according to established guidelines to meet required timelines. 
o Maintaining 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. 
o Informing management of potential safety issues, emerging trends and/or concerns. 

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