Senior Quality Assurance Engineer

OSI Systems; City of Edinburgh; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading healthcare technology company is seeking a Senior Quality Assurance Engineer in Edinburgh. The role involves leading QMS performance and ensuring compliance with regulatory standards for medical devices. Candidates should have over 7 years in Quality or Engineering roles, with strong experience in medical device QMS environments. Excellent communication and organizational skills are essential.

Qualifications

• 7+ years in Quality or Engineering roles.
• 5+ years in medical device regulatory and QMS environments.
• Strong knowledge of technical documentation and change control.

Responsibilities

• Lead internal audits and CAPA activities.
• Monitor product performance and address defects.
• Approve Device History Records for compliance.

Skills

Mentoring design teams

Regulatory submissions

Statistical analysis

Communication skills

Education

Bachelor’s degree in Engineering

Job description

Overview

At Spacelabs Healthcare, we’re 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.

Role Overview

We’re 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.

Responsibilities

Design Control & Product Development

• Mentor design teams on Design Controls, Risk Management, and Electrical Safety.
• Review Engineering Change Orders for sound engineering practices and compliance.
• Support technical documentation including Essential Requirements Checklists and Risk Management Files.
• Collaborate with engineering on regulatory submissions and design planning.

Manufacturing & Process Improvement

• Oversee manufacturing processes, work instructions, and inspection protocols.
• Approve Device History Records to ensure compliance with Device Master Record requirements.
• Conduct 7S-based floor walkthroughs to drive operational improvements.

Post-Market Surveillance & Service

• Monitor product performance and service documentation.
• Escalate and address defects, assess trends, and identify improvement opportunities.

Quality System Administration

• Lead internal audits, CAPA, process change control, and supplier quality activities.
• Maintain compliance with ISO 13485, MDR/MDD, MDSAP, and other global standards.
• Support regulatory filings including 510(k), CE Mark, and IDE submissions.

Material Review Board (MRB)

• Facilitate efficient processing of Nonconforming Material Reports and Rework Orders.
• Track and report MRB metrics to minimize backlog and improve throughput.

Qualifications

• Bachelor’s degree in Engineering, Quality, or related field (e.g., Biomedical, Electrical, Software).
• 7+ years in Quality or Engineering roles.
• 5+ years in medical device regulatory and QMS environments.
• Experience with SaMD or embedded software in medical devices.
• Strong knowledge of technical documentation and change control.
• Proficient in statistical analysis and risk-based QMS activities.
• Excellent communication skills and a proactive, organized approach.