Compliance Examiner Professional

Location: Jacksonville, Florida
Posted On: 5/3/2017
Job Code: FL-Consumer Affairs-
Job Description
Job Description:
This position has the responsibility and authority to process alleged product complaints from initiation to closure, including but not limited to the following as applicable:
• Conduct investigations and evaluate potential impact to the company.
• Perform follow-up communication with customers, coordinate with engineering team and partner within the department to ensure the complaint files are complete and meet all of the regulatory requirements.
• Assist with various tasks and projects as assigned.
• Take necessary steps to identify and drive process improvements.

Position Responsibilities:
• Adheres to all of the regulatory requirements for complaint handling, including the FDA and other competent authorities as needed.
• Communicates with customers and creates records as needed in the complaint handling database.
• Performs follow-up communication to gather information that is relevant to the event and clearly documents in the file.
• Coordinates with Service and Repair to ensure all the product related events are logged in the complaint database, and processed in a timely manner.
• Conducts thorough complaint file investigations and documents the results in respective files.
• Facilitates quality awareness for department and internal customers.
• Performs thorough investigation and determines root cause for product related issues. May contribute to the corrective/preventive actions for product quality issues.
• Identifies high-level complaints or incidents that may have significant impact to the company.
• Notifies management in a timely manner when high-level complaints are identified.
• Assists with internal and external audits as needed.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned.
• Travel requirement: 0%
Category:Non-IT  code:new
Job Requirements
FDA guideline
Technical Writing
cMP regulation
regulatory documentation

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Contact Details
Priyankar Gupta