Quality & Regulatory Engineer

Crux Product Design Ltd; Bristol; On-site; GBP 40,000 - GBP 60,000; Full time

Job summary

A leading medical device consultancy in Bristol is seeking an experienced Quality & Regulatory Engineer to enhance ISO-certified quality management systems. The role focuses on integrating quality in product development, regulatory compliance, and risk management. Applicants should have a strong background in medical device quality assurance, demonstrate problem-solving skills, and possess effective communication abilities. Joining the consultancy offers a collaborative team environment with opportunities for mentorship and professional growth.

Benefits

Dynamic and supportive workplace

Collaboration in a multidisciplinary team

Opportunities for travel

Regular social events

Qualifications

• Relevant sector experience in Medical Device Quality Assurance and Regulatory Compliance.
• Experience in technical documentation and regulatory submissions.
• Up-to-date with industry trends and best practices.

Responsibilities

• Embed quality throughout product development.
• Support validation of QMS systems.
• Contribute to risk management activities.
• Develop training materials to strengthen quality awareness.

Skills

Strong analytical and problem-solving skills

Effective communication skills

Attention to detail

Team collaboration

Knowledge of medical device standards

Proactive problem-solving

Mentoring skills

Education

Degree in a relevant scientific/healthcare-related discipline

Job description

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.

Check out what an opportunity at Crux offers you: Life at Crux