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
· 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.