Job Opportunity for Complaints Coordinator at San Diego CA with direct client. Please go through Detailed Job description below.
Duration: 6-9 months. Contract only
Here is a brief Job description:
• Review and approve complaints to ensure that records meet Philips 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
• 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.
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.