Senior Quality Assurance Engineer

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

Job summary

A leading medical technology firm in Edinburgh seeks a Quality Manager to oversee design controls, regulatory compliance, and operational improvements in medical devices. The ideal candidate will have extensive experience in quality assurance and engineering, with a strong background in medical device regulations. This role focuses on enhancing product quality and ensuring compliance with global standards.

Qualifications

• Minimum 7 years in Quality or Engineering roles.
• 5+ years in medical device regulatory environments.
• Experience with SaMD or embedded software.

Responsibilities

• Mentor design teams on Design Controls and Risk Management.
• Oversee manufacturing processes and inspection protocols.
• Lead internal audits and CAPA activities.

Skills

Quality Management Systems

Regulatory Compliance

Statistical Analysis

Engineering Management

Communication Skills

Education

Bachelor’s degree in Engineering or related field

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.

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.