At a Glance
- Tasks: Lead software quality initiatives for innovative medical and digital products.
- Company: Join a leading company in medical technology with a focus on quality and compliance.
- Benefits: Attractive salary, health benefits, flexible work options, and growth opportunities.
- Other info: Collaborative culture with a commitment to diversity and inclusion.
- Why this job: Make a real difference in healthcare by ensuring high-quality software solutions.
- Qualifications: 10+ years in software quality engineering, preferably in regulated environments.
The predicted salary is between 70000 - 90000 £ per year.
The Sr. Principal Engineer, Quality applies a deep and broad understanding of software engineering principles, quality engineering practices, and regulatory requirements to lead the continuous improvement of software-enabled medical and non-medical products. This role spans regulated medical device software (e.g., IEC 62304) as well as non-medical digital solutions, ensuring scalable, compliant, and high-quality software delivery across diverse platforms. The role plans, executes, and functionally directs quality programs requiring independent judgment, technical authority, and cross‑functional leadership. The individual serves as a recognized technical expert in software quality, and Quality Management System (QMS) integration, ensuring alignment with ISO 13485 and EU MDR requirements while enabling modern software development practices.
Responsibilities
- Lead and govern activities that ensure alignment with Baxter’s Product Lifecycle Management (PDLM) and Change Control Management (CCM) processes and compliance with design controls and quality system regulations.
- Translate Agile software development practices into compliant frameworks that meet Baxter, ISO 13485 and EU MDR expectations, including traceability, documentation, verification, and validation.
- Ensure effective implementation of software design controls, including:
- Software requirements and architecture
- Risk management (software hazard analysis, cybersecurity risk)
- Verification and validation strategies (manual, automated, CI/CD pipelines)
- Configuration and change management
- Lead integration of Quality Management System (QMS) processes into software development workflows, including CAPA and nonconformance handling, complaint handling and feedback loops into Agile backlogs, audit readiness and inspection support.
- Ensure compliance with EU MDR requirements, including:
- Support for technical documentation and software lifecycle evidence
- Alignment of software changes with regulatory impact assessments
- Post-market surveillance inputs (e.g., trending, signal detection)
- Apply advanced quality and engineering tools such as root cause analysis, reliability engineering, and data analytics to improve software quality and system performance.
- Oversee development of technical documentation supporting design history files (DHF) / technical files, software lifecycle documentation (per IEC 62304 where applicable), risk management files, verification and validation reports, and regulatory submissions.
- Serve as subject matter expert for software quality, cybersecurity, and lifecycle management, providing guidance across teams and influencing enterprise‑wide standards.
- Collaborate closely with Quality, Regulatory Affairs, R&D (software and systems), Product Management, Cybersecurity, Clinical, and Manufacturing teams to ensure software products are safe, effective, secure, and compliant.
Qualifications
- Bachelor of Science or Bachelor of Engineering in Software Engineering, Computer Science, Electrical, Biomedical, or related discipline required.
- Master’s degree or PhD preferred with 10+ years of progressive experience in software quality engineering, including regulated medical device software and/or digital health platforms.
- Strong expertise in ISO 13485 Quality Management Systems and EU MDR (Regulation (EU) 2017/745) and software implications.
- Proficiency in software lifecycle standards (e.g., IEC 62304, IEC 82304 where applicable) and FDA software and quality system expectations.
- Proven ability to integrate Agile development practices with regulatory compliance, including traceability, documentation, and change management.
- Broad understanding of software architecture and system integration, cloud-based systems, cybersecurity, and data privacy considerations.
- Strong understanding of software risk management, including hazard analysis and vulnerability management.
- Strong technical leadership with advanced problem-solving, analytical, and decision-making skills.
Sr Principal Engineer - Software Quality in Gloucester employer: Zvh
Baxter is an exceptional employer that fosters a culture of innovation and collaboration, particularly in the field of software quality engineering for medical devices. With a commitment to employee growth, Baxter offers extensive training and development opportunities, ensuring that team members can thrive in their careers while contributing to meaningful advancements in healthcare technology. Located in a dynamic environment, employees benefit from a supportive workplace that values diversity and inclusivity, making it an ideal place for those seeking impactful and rewarding employment.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Principal Engineer - Software Quality in Gloucester
✨Join Local Tech Meetups
Get out there and mingle with fellow developers by joining local tech meetups. It’s a fantastic way to meet people who might be working at Zvh or know someone who does. Plus, you can pick up some trendy tech skills and trends while you're at it!
✨Contribute to Open Source Projects
Show off your coding chops by jumping into open-source projects. Not only does this give you practical experience, but it also gets you noticed in the dev community. You'll create a killer portfolio that speaks volumes about your skills to Zvh.
✨Tap into Online Developer Communities
Don’t underestimate the power of online developer communities like GitHub, Stack Overflow, and even Reddit. Participate in discussions, share your projects, and build your visibility. We can often find opportunities through these channels that can lead to a full-time gig at companies like Zvh.
✨Explore Job Boards Specifically for Tech Roles
Keep your eyes peeled on job boards that focus on tech roles. Sites like TechCareers or Stack Overflow Jobs can often have listings for companies like Zvh that might not show up on broader job sites. Make it a habit to check these regularly, and don’t hesitate to apply directly through our website!
We think you need these skills to ace Sr Principal Engineer - Software Quality in Gloucester
Some tips for your application 🫡
Show off your coding skills:When applying for a software engineering role, it's super important to showcase your coding skills. Make sure your CV includes your tech stack, any relevant programming languages you’re comfortable with, and examples of projects you've worked on. If you have a GitHub profile, link it up! We love to see code in action.
Tailor your portfolio:For a full-time role, we’d expect to see some solid examples of your work in your portfolio. Make sure to include at least two or three projects that highlight your problem-solving skills and your ability to work with different technologies. Focus on the projects that are most relevant to the position at Zvh.
Craft a killer cover letter:Your cover letter is your chance to stand out—make it personal! Explain why you want to work at Zvh and how your skills align with the role. Show us your passion for software development. We dig enthusiastic candidates who understand the value of collaboration and continuous learning!
Be clear and concise:When it comes to writing your CV and cover letter, clarity is key. Avoid jargon that could confuse us and stick to simple, direct language. Highlight your achievements with quantifiable results where possible, and keep everything easy to read. A well-organised application goes a long way!
How to prepare for a job interview at Zvh
✨Brush Up on Your Coding Skills
For a full-time software engineering role, it's crucial that we stay sharp with our coding abilities. Expect technical questions that might involve solving problems on the spot or discussing algorithms. Practise on platforms like LeetCode or HackerRank to get comfortable with the types of questions that often come up.
✨Know Your Tools and Frameworks
Make sure we’re well-acquainted with the tools and technologies listed in the job description. Familiarise ourselves with any specific frameworks or programming languages mentioned. If Zvh uses React or Node.js, for instance, be ready to discuss how we’ve used them in previous projects or coursework.
✨Showcase Your Projects
Bring along a portfolio that highlights our best work. This could be code samples, GitHub repositories, or any side projects we’ve built. Make sure we can talk through our thought process for each project, especially the challenges we faced and how we solved them—this shows our problem-solving skills in action.
✨Prepare for Behavioural Questions
While technical skills are key, full-time positions also require cultural fit. Be ready to discuss our previous experiences and how we handle teamwork, conflict, and deadlines. Brush up on the STAR method—Situation, Task, Action, Result—to clearly articulate our past experiences when discussing how we've contributed to a team.
