Quality Systems Engineer: ISO 13485 & Change Control

AliveDx; Penicuik; On-site; GBP 40,000 - 55,000; Full time

Benefits offered by this job

Private medical cover

Life assurance

Additional annual leave

Cycle to work

Marketplace discounts

Job summary

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

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Minimum 3 years in document control or quality assurance in ISO 13485 GMP or 21CFR Part 820 environment.
• Experience with document management systems and electronic QMS.

Responsibilities

• Manage document control: creation, review, approval, distribution, retrieval.
• Oversee change control; log, evaluate and route engineering change requests.
• Lead change control board meetings and guide change.
• Manage product and process failure investigations and root cause analysis.
• Support external audits and regulatory compliance.

Skills

Document control

Quality assurance

Root cause analysis

Auditing

Education

Bachelor's degree in Quality Assurance, Life Sciences, Engineering or related

Tools

Document management system

Electronic quality management system

Job description

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