Senior Software Quality Engineer

Description

The company builds medical technology and has about 95,000 employees in more than 150 countries, serving over 72 million patients a year.

This is a Senior Software Quality Engineer role in the surgical operating unit, within the new product development quality team.

You will support software quality from early design through release and post-market support, helping ensure products are safe, effective, reliable and compliant with applicable standards and internal procedures.

You will work with software engineering, systems engineering, regulatory and quality teams on design quality, risk management, verification and validation, documentation and continuous improvement.

Responsibilities

• Support software quality across the full lifecycle, from requirements and design through verification, validation, release and post-market support.
• Work with project and development teams to keep work compliant with company procedures, applicable standards and regulatory requirements.
• Give early quality input on software requirements, architecture, algorithms, code and technical design reviews.
• Review requirements, design outputs, test cases and results, and traceability documents for completeness, clarity and compliance.
• Support software risk management, including SFMEA, hazard analysis, risk mitigation and verification.
• Support verification and validation planning, execution and documentation, along with defect investigations, root cause analysis and CAPA activities.
• Contribute to software configuration management, change control, release readiness and documentation consistency.
• Support internal and external audits and regulatory readiness, monitor software quality metrics and drive process improvements.
• Provide quality input on reliability, cybersecurity, usability and other software quality considerations throughout development.

Requirements

• Bachelor's degree in Engineering, Computer Science, Software Engineering, Science or a related technical field.
• Experience in software quality, software development, verification and validation, or a related engineering or quality role.
• Working knowledge of software development lifecycle activities.
• Understanding of design controls, requirements traceability, verification and validation, and risk management.
• Strong analytical, documentation and problem-solving skills.
• Effective communication skills and the ability to work across multiple functions and organizational levels.
• Ability to manage multiple priorities and deliver work on time.
• Preferred: experience in medical device or other regulated product development environments.
• Preferred: familiarity with standards and regulations such as ISO 13485, ISO 14971, IEC 62304, 21 CFR 820 and IEC 60601-1.
• Preferred: knowledge of Agile development methodology.
• Preferred: experience with embedded software, mobile applications or medical device software.
• Preferred: familiarity with cybersecurity evaluations and how threats can translate to patient safety risks.
• Preferred: experience supporting audits, inspections or regulatory submissions.

Conditions

You will work onsite a minimum of 3-4 days a week, which the company sees as key to professional growth and cross-functional collaboration.

The above statements describe the general nature and level of the work, but are not a complete list of all duties and skills for the role.

The company is aware of recruitment fraud and only recruits through its official channels; it will never ask for payment or sensitive personal information early in hiring.

Benefits

• Competitive salary and flexible benefits package.
• A wide range of benefits, resources and compensation plans to support you at every career and life stage.
• Salary range in the United Kingdom: 76,800.00 GBP to 115,200.00 GBP, with the final figure set by objective, job-related criteria such as relevant experience, skills and qualifications, under the company's compensation framework.
• Eligible for the company Incentive Plan (MIP), a short-term incentive.