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 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 For

Essential

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.

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.