Senior Medical Device QA Engineer — Regulatory & Quality

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

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.