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Advanced Quality Engineer
2 weeks ago
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 senior-level 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
Principal Responsibilities
As an Advanced Quality Engineer, you'll play a key role in maintaining and evolving our ISO 9001, ISO 13485, and ISO 14001 certified Quality Management System (QMS). You'll lead quality initiatives across:
- Human Factors & Usability Engineering
- Device Design & Development
- Risk Management & ISO 14971 Compliance
- Computer System Validation
- Quality Agreements & Contracts
- Sustainability Reporting & ESG Metrics
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 ForEssential
- Proven experience applying quality principles to Human Factors, Usability, and Risk Management in line with ISO 13485, IEC , 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.
Desirable
- 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.
