Overview
Join to apply for the Advanced Quality Engineer role at Crux Product Design.
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 an Advanced Quality Engineer, a role that blends technical expertise with a drive to ensure that quality management strategies are aligned with the latest regulatory requirements.
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 Advanced Quality Engineer to join our growing team and lead 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
Core Responsibilities
* Quality and regulatory support for the planning and execution of Human Factors and Usability studies in compliance with EU and US regulations.
* Quality and regulatory support for the planning and execution of Device Design & Development in compliance with EU and US regulations.
* Quality and regulatory support for the planning and execution of pre-clinical and clinical research activities in compliance with EU and US regulations.
* Ensure device risk management aligns with ISO 14971 and current regulatory guidance.
* Oversee validation of computer-based systems used in regulatory and QMS activities.
* Maintain and improve QMS processes, including documentation, audits, and change control.
* Build trusted client relationships and identify opportunities for process improvement.
* Manage quality agreements and support contract development.
* Drive sustainability reporting and contribute to Crux’s ESG strategy.
What We’re Looking For
* Proven experience applying quality principles to Human Factors, Usability, and Risk Management in line with ISO 13485, IEC 62366-1, ISO 14971, and FDA guidance.
* Strong cross-functional collaboration skills and stakeholder engagement.
* Experience validating software systems within a QMS context.
* Skilled in medical device risk management and usability integration.
* Familiarity with quality agreements and contract implementation.
* Excellent communication, planning, and attention to detail.
* Willingness to travel to support global project delivery.
* Strong degree in a relevant scientific/healthcare-related discipline.
* Consultancy experience in medical, pharma, or health sectors.
* Strong academic background.
* 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.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance and Other
Industries
* Design Services, Engineering Services, and Medical Equipment Manufacturing
Bristol, England, United Kingdom
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