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- Tasks: Shape the future of medical devices by ensuring quality and regulatory compliance.
- Company: Join Crux, a dynamic consultancy at the forefront of healthcare innovation.
- Benefits: Collaborative culture, travel opportunities, and a supportive workplace.
- Why this job: Make a real impact on life-changing healthcare technologies with top pharma clients.
- Qualifications: Degree in a relevant field and experience in Medical Device Quality Assurance.
- Other info: Be part of a passionate team that values curiosity and collaboration.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Are you passionate about shaping the future of medical device quality? Join a team of expert engineers and human factors specialists driving innovation for the world’s leading pharmaceutical and device companies. We’re hiring in our Bristol office for a role that blends quality management and regulatory awareness to ensure that device development activities align with the latest guidelines.
At Crux, we believe that curiosity drives innovation. As a specialist consultancy at the forefront of medical device development, we deliver safe, user‑centred solutions that transform healthcare globally. We’re looking for an experienced and passionate Quality & Regulatory Engineer to join our growing team and support impactful work across a diverse portfolio of global projects.
Why Crux?
- Work with top pharma clients on cutting‑edge medical device projects.
- Collaborate with a multidisciplinary team across our Bristol (UK) and Boston (US) offices.
- Travel opportunities to support global project delivery.
- Influence the development of life‑changing healthcare technologies.
- Be part of a consultancy that values curiosity, integrity, and collaboration.
As a Quality & Regulatory Engineer, you’ll help maintain and improve our ISO‑certified QMS across human factors, device development, risk management, system validation, and sustainability. You will:
- Embed quality throughout product development.
- Support validation of QMS systems.
- Support audits and change control.
- Contribute to risk management activities.
- Develop training materials to strengthen quality awareness.
What We’re Looking For
- A good degree in a relevant scientific/healthcare‑related discipline (preferably Masters level).
- Strong relevant sector experience in Medical Device Quality Assurance and Regulatory Compliance.
- Awareness of medical device related standards, regulations and guidelines (IEC 62366‑1, ISO 14971, EU MDR, and FDA guidance).
- Strong analytical and problem‑solving skills.
- Excellent attention to detail and organisational skills.
- Effective communication skills and the ability to work within a collaborative team environment.
- Experience in technical documentation and regulatory submissions.
- Confident communicator and proactive problem‑solver.
- Passion for mentoring and knowledge sharing.
- Up‑to‑date with industry trends and best practices.
- Curious, collaborative, and committed to making a difference.
Why you’ll love working here...
We are a dynamic and fast‑growing design and engineering consultancy that takes pride in its outstanding work and warm and supportive workplace. As part of our team, you’ll be working within a family of high‑performing experts. Our strong community is built upon effective communication and happy employees, collaboration in project work and regular social events are the norm.
Quality & Regulatory Engineer in West Bromwich employer: Crux Product Design
Contact Detail:
Crux Product Design Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality & Regulatory Engineer in West Bromwich
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device field on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Show your passion! When you get an interview, let your enthusiasm for quality and regulatory standards shine through. Share examples of how you've made a difference in past roles.
✨Tip Number 3
Prepare for those tricky questions! Brush up on the latest regulations and standards like IEC 62366-1 and ISO 14971. Being well-versed will show you're serious about the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Quality & Regulatory Engineer in West Bromwich
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality & Regulatory Engineer role. Highlight your relevant experience in medical device quality assurance and regulatory compliance, and don’t forget to mention any specific standards you’re familiar with, like IEC 62366-1 or ISO 14971.
Craft a Compelling Cover Letter: Your cover letter is your chance to show us your passion for the role. Share why you’re excited about shaping the future of medical devices and how your skills align with our mission at Crux. Be genuine and let your personality shine through!
Showcase Your Problem-Solving Skills: In your application, give examples of how you've tackled challenges in previous roles. We love curious minds that can think critically and solve problems effectively, so don’t hold back on sharing your success stories!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re genuinely interested in joining our team at Crux!
How to prepare for a job interview at Crux Product Design
✨Know Your Standards
Familiarise yourself with key medical device standards and regulations like IEC 62366-1, ISO 14971, and EU MDR. Being able to discuss these in detail will show your expertise and passion for the role.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled quality assurance challenges in the past. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your analytical abilities.
✨Emphasise Collaboration
Since this role involves working with multidisciplinary teams, be ready to discuss your experience in collaborative environments. Share specific instances where teamwork led to successful project outcomes.
✨Ask Insightful Questions
Prepare thoughtful questions about Crux's approach to quality management and regulatory compliance. This not only shows your interest but also your curiosity and commitment to contributing positively to their projects.
