What are the responsibilities and job description for the Medical Device File Compliance Coordinator position at Randstad Global Capability Center?
Description : Must haves :
Proficiency in Microsoft Office and Excel
Ability to follow written procedures
Detail oriented
Ability to work autonomously
This position is responsible for the development, maintenance, and management of Medical Device Files (MDFs) in accordance with ISO 13485 standards. This position will also be responsible for performing change controls, creating, and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System.
Description of work :
- Developing, reviewing, maintaining, and updating medical device files in accordance with ISO 13485.
- Coordinating across functions (development, operations, engineering, and quality) to ensure that all necessary documentation is collected and properly recorded.
- Drive resolution on any non-compliance issues identified during creation of MDFs.
- Initiates change controls and document change requests to update procedures and processes.
- Supports or leads continuous improvement initiatives for quality management system processes.
- Other duties as required.
Minimum Qualifications :
Skills / Experience :
