Quality and Regulatory Engineer

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

Job summary

A consultancy in medical device development is seeking a Quality & Regulatory Engineer to support their Bristol office. This essential role involves maintaining the ISO-certified Quality Management System, managing risks, and ensuring compliance with medical device regulations. Candidates should have a degree in a relevant field and strong experience in quality assurance. This position offers the chance to work on innovative medical projects, with opportunities for collaboration and travel for global project delivery.

Qualifications

• Strong relevant sector experience in Medical Device Quality Assurance and Regulatory Compliance.
• Awareness of medical device related standards, regulations and guidelines such as IEC 62366-1, ISO 14971, EU MDR, and FDA guidance.

Responsibilities

• Embed quality throughout product development.
• Support validation of QMS systems.
• Contribute to risk management activities.

Skills

Strong analytical and problem-solving skills

Excellent attention to detail

Effective communication skills

Education

A good degree in a relevant scientific/healthcare-related discipline

Job description

Position Overview

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

Principal Responsibilities

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

Essential

• 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.

Desirable

• 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.