Document Control Coordinator, EMEA Timezone

This is a fully remote position, open to applicants in Malaysia.

📋 Description

• Implement and uphold document control procedures that align with Quality Management Systems throughout the organization.

• Oversee Change Notices, guaranteeing the timely and precise documentation of product and process modifications within the electronic document management system and the ERP system (Oracle).

• Collaborate with engineering, manufacturing, regulatory, marketing teams, and other departments as necessary to assure that changes are accurately documented and communicated.

• Ensure document accuracy, version control, and traceability across various systems.

• Support compliance with regulatory requirements, ensuring that documentation systems are ready for audits and adhere to internal policies and external regulations.

• Assist in both internal and external audits, including preparation and follow-up tasks.

• Identify areas for process enhancement and contribute to continuous improvement initiatives.

• Maintain secure and precise record-keeping systems.

⛳️ Requirements

• Experience in document control, quality assurance, or regulated settings (medical device/pharma preferred).

• Familiarity with QMS and regulatory standards (e.g., ISO 13485, GMP, FDA requirements) is highly advantageous.

• Understanding of engineering change management processes (ECN/ECR).

• Exceptional attention to detail and strong organizational skills.

• Capability to handle multiple tasks and work autonomously.

• Excellent communication skills with the ability to collaborate effectively across teams.

• Proficient in utilizing document management systems and digital tools.

• Vocational training or equivalent experience in a relevant field.

🏝️ Benefits

• Opportunities for career advancement and professional development.

• Chance to contribute to global quality systems and processes.