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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Quality Systems Engineer: ISO 13485 & Change Control in Penicuik employer: AliveDx
At AliveDx, we pride ourselves on being an exceptional employer, offering a dynamic and innovative work environment that prioritises patient care and employee growth. Located near Edinburgh, our facility fosters a culture of collaboration and continuous improvement, providing employees with opportunities to develop their skills while enjoying a flexible working atmosphere and a comprehensive benefits package, including private medical cover and additional annual leave. Join us in making a meaningful impact in the field of diagnostics and be part of a team that values your contributions and encourages your passion for innovation.
