Quality Systems Engineer: ISO 13485 & Change Control

AliveDx is seeking a Quality Systems Engineer to join the Quality and Regulatory Affairs team at our ARC site near Penicuik, EH26 0BF. The role is full-time, 37.5 hours per week, focusing on document control, change control and failure investigations within an ISO 13485 and FDA 21 CFR Part 820 environment.

You will maintain QMS documentation, enforce version control, coach cross-functional teams in root cause analysis, and support external audits to ensure regulatory compliance across quality

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