Senior Quality Assurance Engineer

Velo Mini Edinburgh, Scotland, United Kingdom

At Spacelabs Healthcare, we are committed to transforming healthcare through continuous innovation. Our scalable solutions deliver critical patient data across local and remote systems, empowering better decisions, improving efficiency, and enhancing patient safety.

We are seeking a Senior Quality Assurance Engineer to lead and support Quality Management System (QMS) performance across design, manufacturing, service, and compliance functions. This role is pivotal in ensuring our medical devices are safe, effective, and compliant with global standards.

Provide Quality System Design Control mentoring to ensure product design teams use critical thinking. Ensure all Design Control, Risk Management, Electrical Safety, and associated processes, policies, procedures, and records are correctly performed, documented, and timely. Review Engineering Change Orders and proposed changes to ensure sound engineering practice, effective design, product safety, and Quality System compliance. Ensure product Design Change activities move ahead in a timely and effective manner.

Monitor and ensure efficient product manufacturing processes, facilitating adequate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling.

Facilitate processing of Nonconforming Material Reports and Rework Orders. Capture, monitor, and report process performance metrics to ensure timely MRB throughput and minimized quarantine backlog.

Ensure post‑market activities maintain intended device performance. Document service and support activities, escalated defect handling, and assess performance trends to drive improvement opportunities.

Conduct QMS administration activities, including Internal Quality Audits, Corrective and Preventive Action, Process Change Control, Exception Handling, process improvement and maintenance, supplier quality, external audit support, and related activities. Follow guidance of RA/QA Management and help other functions understand and fulfill obligations to meet quality objectives. Participate in cross‑functional design teams, support maintenance of Essential Requirements Checklists, Technical Documentation Files, and ensure compliance to regulatory standards.

• Ensure high quality of products and services, by implementing and maintaining the Quality Management System.
• Ensure QMS activities are risk‑based.
• Perform, report, and drive remediation from Internal Quality Audits and participate in third‑party audit and inspection activities (MDR, MDSAP, etc.).
• Routinely pursue more efficient and effective operations (continual improvement). Support the development teams of all business areas, working within project teams on new or sustaining product development projects.
• Support maintenance of Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files.
• Assist with compliance to changes to standards such as EN 60601‑1, ROHS3, REACH, and global regulatory requirements applicable to Spacelabs products.
• Provide Quality System guidance to product design teams.
• Collaborate with engineering to determine and execute engineering design and development planning in support of regulatory submissions.
• Review Engineering Change Requests and Engineering Change Orders to identify critical components, defects in drawings/schematics, effective and adequate design documentation, product safety, and Quality System compliance.
• Assist with creation, maintenance, and performance of QMS change management tools:
  Corrective Action Reports (CARs), Preventive Action Reports (PARs), and Process Change Orders (PCOs).
• Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements.
• Review and approve Device History Record (DHR) deliverables to ensure compliance with Mandatory Device Master Record (DMR) requirements.
• Perform Manufacturing floor walkthroughs based on 7S criteria to…