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)
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.
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