Job Opportunity for Post Market Surveillance Analyst at Colorado Springs CO with direct client. Please go through Detailed Job description below.
Duration: 9-12 months. Contract only
Here is a brief Job description:
In this role, you have the opportunity to
Conduct user acceptance testing for the Complaint Management System. Provide technical expertise in the areas of complaint handling, failure analysis, and adverse event reporting. Work with engineers to perform standard and non-standardization failure investigations of returned products. Document and analyze complaint data for issues/trends.
• Perform user acceptance testing for Complaint Handling System, CATSWeb
• Enter complaints into the complaint database in a timely manner, normally the same day received
• Send a complaint acknowledgement of receipt letter to physicians through the appropriate SPNC sales representative as required
• Under supervision, determine if the complaint involves a reportable Adverse Event
• Communicate with sales representatives, field service engineers, hospital risk management, physicians, lab personnel, etc. in order to obtain the information required in order to complete the complaint form and adverse event reports
• Under supervision, prepare adverse event reports and send them to the appropriate regulatory body (FDA, Competent Authorities) within the required timeframe
• Coordinate with field service engineers to obtain and/or clarify laser failure investigations
• Complete all required documentation on the complaint form
• Send an investigation summary report to the sales representative in order to review with the physician as required
• Work with the SPNC receiving department personnel to obtain returned devices
• Perform decontamination process for returned devices
• Schedule and participate in failure investigations with post-market and the engineering groups
• Forward the completed investigation form to the designated individual for completion and closing of the complaint
• Provide input for product and process improvements based on failure investigations
• Follow current policies and procedures to ensure compliance with all US and international regulations relating to complaint reporting
• Participate in both internal and external quality audits (FDA, BSI, PMDA or others)
• Perform complaint database searches for input to annual reports, submissions, corrective actions or as requested for engineering. sales/marketing, etc.
• Provide complaint metrics used to monitor for monitoring
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.