At a Glance
- Tasks: Ensure software quality in medical devices and collaborate with global teams.
- Company: Join Corin, a leader in orthopaedic innovation and technology.
- Benefits: Enjoy 25 days holiday, excellent pension, private medical insurance, and more.
- Other info: Dynamic work environment with opportunities for continuous improvement and career growth.
- Why this job: Make a real impact on patient outcomes with cutting-edge technologies.
- Qualifications: 5-7 years in Quality Assurance and strong knowledge of medical device regulations.
The predicted salary is between 55000 - 65000 £ per year.
- Senior Software Quality Engineer
- Corin is seeking an experienced and motivated
Senior Software Quality Engineer to support and oversee system and software development activities across our Global Technology Team.
This is a critical role within our orthopaedic medical device business, ensuring that software and system development processes comply with FDA, ISO and European Medical Device regulations and standards.
You will work closely with Software Development, Product Development, Quality, Regulatory and external suppliers to drive quality excellence throughout the product lifecycle.
The successful candidate will play a key role in maintaining and continuously improving software quality processes, supporting compliance to standards such as
ISO 13485, ISO 14971 and IEC 62304 , while helping to deliver innovative technologies that improve patient outcomes worldwide.
What you’ll do
- Software & System Quality Oversight
- Provide expert quality assurance guidance and oversight for software and system development activities.
- Partner with cross-functional global teams throughout the product development lifecycle.
- Review software project documentation to ensure compliance with regulatory and quality requirements.
- Participate in design reviews, software and system risk assessments, and project milestone reviews.
- Collaborate with Software and Product Development teams to define requirements and establish appropriate verification and validation strategies.
- Compliance & Quality Systems
- Support the application, compliance and continuous improvement of policies, procedures and quality system documentation related to:
- Software development and validation.
- Risk management.
- Cybersecurity compliance.
- Software and system verification and validation.
- Quality investigations.
- Requirements traceability.
- Perform gap assessments of Software Development Lifecycle (SDLC) processes against relevant standards, including IEC 62304 and computer system validation requirements.
- Develop and implement procedures, controls and quality processes that support a compliant SDLC framework.
- Promote awareness and understanding of applicable regulatory requirements, quality standards and company procedures across the organization.
- Supplier Quality Management
- Provide Quality Assurance oversight for software suppliers and service providers.
- Interface with suppliers to ensure software deliverables and specifications meet defined requirements.
- Lead supplier audits, assessments and qualification activities for software vendors and service providers.
- Quality Improvement & Auditing
- Lead and support Corrective and Preventive Actions (CAPA), quality investigations and complaint handling activities.
- Conduct internal audits of Quality System processes to verify compliance with regulatory requirements and internal procedures.
- Support external regulatory and certification audits, including preparation, participation and responses to audit findings.
- Identify and implement improvements to Quality Management System processes and Standard Operating Procedures (SOPs) to ensure ongoing compliance and operational effectiveness.
About You
You are a collaborative quality professional with strong experience in medical device software development and quality systems.
You have a passion for compliance, continuous improvement and innovation, and are comfortable working across multiple projects in a fast-paced global environment.
Essential Knowledge & Skills
- Bachelor's degree in Engineering, Life Sciences, Medical Technology or a related discipline.
- Minimum of
5–7 years' experience within Quality Assurance, Medical Devices and Software Development environments.
• Strong working knowledge of
- Experience supporting product and software development lifecycles.
• Knowledge of FDA regulations, including
- FDA software validation and software development guidance
- Ability to manage multiple projects and competing priorities effectively.
- Strong problem-solving skills and the ability to work independently and collaboratively.
- Excellent communication, stakeholder management and interpersonal skills.
- Self-motivated, results-oriented and quality-focused approach.
- Ability to drive continuous improvement and influence positive change across teams.
Desirable Qualifications & Experience
- Trained Internal Quality System Auditor and/or Software Quality Auditor.
- Experience with Medical Device Regulation (MDR) and MDSAP requirements.
• Knowledge of
- NIST Cybersecurity Framework
- FDA Pre-Market and Post-Market Cybersecurity Guidance
- Experience supporting cybersecurity compliance within regulated medical device environments.
Why Join Corin?
Corin is a growing global orthopaedic innovation business, with a vision to revolutionize the field, by integrating advanced robotic and AI technologies (Apollo, OMNIBotics and OPS) for planning, implementation, and continuous learning with its unique combination of clinically proven hip and knee implants.
Since its inception nearly 40 years ago, Corin has strived to maximize healthcare value by providing a fast, positive, and assured return to the quality of life for people all over the world.
Our revolutionary technologies enable patients, surgeons, and healthcare providers to connect more closely than ever.
For further information on who we are, our products and services, please visit www. coringroup. com
Our benefits, what’s in it for you
In addition to your salary, support and opportunity to work in a hybrid environment you will also receive
- 25 days holiday plus bank holidays
- Excellent pension – starts at 6%, going up to 9.7% after 18 months.
- Life assurance – Six times your basic salary
- Private medical insurance with BUPA for you and your family
- Free annual eye tests and flu vaccinations
- Employee referral program where you can earn up to £1,000 for each successful hire you recommend
StudySmarter Expert Advice🤫
We think this is how you could land Senior Software Quality Engineer 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 Corin Group 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 Corin Group.
✨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 Corin Group.
✨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 Corin Group 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 Senior Software Quality Engineer 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 Corin Group.
Craft a killer cover letter:Your cover letter is your chance to stand out—make it personal! Explain why you want to work at Corin Group 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 Corin Group
✨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 Corin Group 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.
