Senior Software Quality Engineer - Medical Devices (Hybrid)

Colonial Group; Cirencester; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

25 days holiday plus bank holidays

Excellent pension – starts at 6% to 9.

Life assurance – Six times your basic

Private medical insurance with BUPA

Free annual eye tests and flu vaccines

Employee referral program (£1,000)

Job summary

Corin Group is seeking a Senior Software Quality Engineer to oversee software and system development activities across its Global Technology Team. You will ensure compliance with FDA, ISO, and European Medical Device standards and drive quality improvements across multiple projects in a fast-paced environment.

The role involves risk assessments, validation strategies, supplier quality oversight, and supporting regulatory audits in a hybrid work setting in the UK.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Medical Technology or related discipline.
• Minimum 5–7 years’ experience within Quality Assurance, Medical Devices and Software Development environments.
• Experience with regulatory standards and medical device software quality systems.

Responsibilities

• Provide expert quality assurance guidance for software and system development activities.
• Partner with cross-functional global teams across the product lifecycle.
• Review software project documentation to ensure regulatory and quality compliance.
• Lead audits, CAPA, and continuous improvement of quality systems.
• Support cybersecurity compliance and regulatory audits.

Skills

Quality Assurance

Medical Devices

Regulatory Knowledge

Cross-functional Collaboration

Regulatory Auditing

Education

Bachelor's degree in Engineering, Life Sciences, Medical Technology or related

Tools

ISO 13485

ISO 14971

IEC 62304

FDA 21 CFR Part 820

FDA 21 CFR Part 11

NIST Cybersecurity Framework

Job description

Corin Group is seeking a Senior Software Quality Engineer to oversee software and system development activities across its Global Technology Team. You will ensure compliance with FDA, ISO, and European Medical Device standards and drive quality improvements across multiple projects in a fast-paced environment.

The role involves risk assessments, validation strategies, supplier quality oversight, and supporting regulatory audits in a hybrid work setting in the UK.