Complaints Coordinator

We have Job Opportunity for Complaints Coordinator  at San Diego CA with direct client. Please go through Detailed Job description below. 
Duration: 3-6 months. Contract only    
Here is a brief Job description:
This is a complaints coordinator position (not customer service rep II) for medical device products 
 
·         Review and approve complaints to ensure that records meet 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 report ability and escalate to the safety teams for report ability 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 
 
Minimum requirements 
·         Effective communication skills needed to provide clear and concise information. 
·         Ability to read, write and speak English fluently 
·         Solid knowledge of word processing, spreadsheet, database and presentation applications 
·         Demonstrated organizational skills a must. 
 
At least one of the following 
·         Prior Complaint Handling Experience in Pharma and/or Medical devices 
·         Catheter Lab Experience 
·         Bachelor's/Associates degree or Certificate preferably in an engineering discipline or of a clinical nature 
·         Experience in Medical 
·         Device Industry 
·         Experience with FDA/QSR requirement & quality systems in Pharma and/or Medical devices (i.e. 21 CFR Part 820, Quality System Regulations , 21 CFR Part 803, Medical Device Reporting, The Privacy Rule, HIPAA , ISO 13485)
 
If you have the above qualification and interested to apply please reply with your updated resume, contact no. and expected pay rate and I will contact you to discuss further. 

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