Qa Coordinator

QA Coordinator Overview

• The QA Coordinator role focuses on ensuring compliance with quality management systems and regulatory standards within the medical device industry.
• Assist in processing recalls, complaints, and adverse events to meet local and national requirements.
• Support the implementation of policies for effective quality management systems and regulatory compliance.
• Maintain recall records and files, ensuring accurate documentation and timely reporting to regulatory authorities.
• Utilize SAP and other software tools for tracking, reporting, and maintaining complaint-related information.
• Collaborate with customers and internal teams to gather complaint-related information and ensure resolution.
• Provide detailed reports and status updates for management review and regulatory submissions.
• Contribute to the annual renewal of establishment registrations and maintain vigilance system support tasks.

QA Coordinator Key Responsibilities & Duties

• Process recalls, including customer notifications, delivery confirmations, and regulatory submissions.
• Track and ship returned parts, preparing documentation for complaint investigations.
• Interface with customers to obtain complaint-related information and generate closure responses.
• Submit Medical Device Reports (MDRs) to FDA, ensuring compliance with regulations.
• Utilize SAP for part return reporting and maintain complaint files using global software tools.
• Generate detailed database reports and status updates for management review.
• Support annual establishment registration renewals and maintain knowledge of relevant regulations.
• Perform other assigned duties, contributing to the vigilance system and quality objectives.

QA Coordinator Job Requirements

• Associate degree in a related field preferred; equivalent experience considered.
• Minimum 2 years of experience in a regulatory or quality role within a medical device company.
• Knowledge of US FDA's Quality System and Medical Device Reporting Regulations strongly preferred.
• Proficiency in Microsoft Office applications; SAP experience is advantageous.
• Strong organizational skills and excellent written and oral communication abilities.
• Ability to work in an office environment with significant computer and telephone use.
• Demonstrated professionalism, confidentiality, and adherence to company principles and conduct.