Document Control Engineer

AliveDx is recruiting for a Document Control Engineer to join the Quality and Regulatory Affairs team based at our ARC site near Penicuik. The role is a full-time, permanent position working 37.5 working hours.

Requirements

• Manage the document control system, including document creation, review, approval, distribution, and retrieval processes, in compliance with ISO 13485 requirements.
• Ensure that all documents are maintained according to the company's quality management system (QMS).
• Establish and enforce version control to maintain accurate and up-to-date documents.
• Collaborate with department heads and subject matter experts to create and update standard operating procedures (SOPs), work instructions, forms, policies, and other controlled documents.
• Facilitate and coordinate document review and approval workflows, ensuring timely completion.
• Ensure that all documentation is maintained in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Implement and maintain a secure system for archiving and retaining quality records according to regulatory and company retention policies.
• Conduct regular document audits to ensure compliance with company policies and regulatory requirements

Benefits

• Flexible working environment
• Core and flexible benefits
• Private medical cover
• Life assurance
• Additional annual leave
• Cycle to work
• Technology
• Experience days
• Access to marketplace discounts