Job Description

Job Overview:

• Documentation Review
• Ensure timely QA review of documentation to verify compliance to SOP’s and regulatory requirements.
• Perform final review and release of finished Medical Device History Records.
• Identify and initiate NCA for nonconformance found during the final review of DHR’s.
• Maintain expertise in quality systems (e.g. assist and review SOP’s, initiate change control)
• Ensure training requirements are met and records are up to date.
• Maintain and update departmental metrics and required reports.
• Assist with continuous improvement initiatives / projects within the Manufacturing and Quality departments.

KEY RESPONSIBILITIES:

• Processing the field inquiries received by phone, electronic or verbal correspondence in accordance to applicable SOP(s).
• Will also be responsible for reviewing complaint records to ensure the records are completed in accordance with global regulations and internal procedures.
• Provide technical support and remote troubleshooting guidance as needed.
• Conduct follow-up activities to be able to close records in a timely manner.
• Complete investigations which may include execution of product returns and subsequent evaluations, reviews of manufacturing records, and assuring proper approvals are obtained as part of closures.
• Execute the activities of processing complaints in accordance with the Company Quality System.