Senior QA Validation Engineer

SoCode Recruitment; Cambridge; On-site; GBP 80,000 - 120,000; Full time

Job summary

SoCode Recruitment is seeking a Senior QA Validation Engineer in Cambridge to support development of safety-critical software in a regulated environment. On-site with occasional flexibility, you will lead verification, validation, and compliance activities across the full software lifecycle.

You will develop test strategies, design automated and manual tests, and ensure traceability to requirements while coordinating with cross-functional teams and supporting audits and regulatory submissions as

Qualifications

• Experience in software QA within a regulated industry.
• Proven ability to define and execute test strategies across verification levels.
• Experience with automated and manual testing approaches.
• Familiarity with eQMS and controlled documentation.
• Strong analytical and problem-solving skills.
• Excellent communication with cross-functional teams.

Responsibilities

• Develop and maintain verification and validation plans, protocols, and reports.
• Define test strategies for unit, integration, system, and end-to-end testing.
• Design and maintain automated test frameworks for CI/CD.
• Execute manual testing where needed and ensure traceability to requirements.
• Support audits and regulatory submissions as required.
• Collaborate with software, hardware, and regulatory teams to resolve quality issues.

Skills

Software verification

Software validation

Automated testing

Manual testing

Test strategy development

Quality assurance

Regulatory compliance

C/C++

Python

Test tooling

eQMS knowledge

Education

Bachelor's or Master's degree in Engineering

Biomedical Engineering or related field

Job description

Job Title: Senior QA Validation Engineer

Location - Cambridge:

On Site (some flex on occasion)

Salary

£80k - £100k (depending on experience) + up to 10% bonus (company performance dependent) + equity

Overview

We are seeking an experienced Senior QA Validation Engineer to support the development and delivery of complex, safety-critical software systems within a regulated environment. This role combines software verification and validation activities with quality and compliance responsibilities, ensuring that software products are developed, tested, and documented in accordance with established quality management processes and industry standards. Working closely with cross-functional engineering teams, you will contribute throughout the software development lifecycle, from test strategy and verification planning through to execution, reporting, and regulatory compliance activities.

Key Responsibilities

Verification & Validation

• Develop, maintain, and execute software verification and validation plans, protocols, and reports.
• Define and implement test strategies covering unit, integration, system, and end-to-end testing activities.
• Design, develop, and maintain automated test frameworks and test suites to support continuous integration and release activities.
• Create and maintain test tools and processes to improve test coverage, efficiency, and repeatability.
• Execute manual testing where automation is not feasible or appropriate.
• Establish and maintain traceability between requirements, design artefacts, risk controls, and verification activities.
• Analyse test results, investigate defects, and support root cause analysis and corrective actions.

Quality & Compliance

• Ensure testing activities are conducted in accordance with established quality management processes and applicable regulatory requirements.
• Support software risk management activities throughout the product lifecycle.
• Author, review, and maintain validation documentation, including test plans, test cases, protocols, reports, and supporting quality records.
• Contribute to design history, requirements management, and other controlled documentation activities.
• Support internal and external audits, inspections, and regulatory submissions where required.

Collaboration

• Work closely with software, systems, quality, and regulatory teams to ensure product quality objectives are achieved.
• Collaborate with stakeholders across engineering and operations to resolve quality issues and improve development processes.
• Promote best practices in software testing, validation, and quality assurance.

Skills & Experience

• Strong background in software verification, validation, and quality assurance within a regulated industry.
• Experience developing and executing automated and manual test strategies.
• Working knowledge of C/C++ and Python for test development and automation.
• Experience testing complex integrated systems involving software, hardware, and electromechanical components.
• Familiarity with requirements management, electronic quality management systems (eQMS), and controlled documentation processes.
• Ability to analyse technical issues, identify risks, and develop practical solutions.
• Excellent communication and stakeholder management skills.

Preferred Experience

• Experience working within regulated product development environments.
• Knowledge of software lifecycle, risk management, and quality management standards relevant to safety-critical systems.
• Experience supporting compliance, validation, and regulatory documentation activities.

Qualifications

• Bachelor's or Master's degree in Engineering, Computer Science, Biomedical Engineering, or a related technical discipline.
• Several years of experience in software quality assurance, verification, validation, or test engineering within a regulated industry.

Working Environment

• Collaborative, fast-paced engineering environment.
• Opportunity to work across software quality, validation, compliance, and process improvement activities.
• Occasional travel may be required.