Advanced Quality Engineer
Join our Bristol office as an experienced Advanced Quality Engineer at Crux Product Design.
We’re a leading medical device consultancy delivering safe, user‑centred solutions that transform global healthcare.
Why Crux?
* Work with top pharmaceutical and device clients.
* Collaborate across Bristol (UK) and Boston (US) offices.
* Travel opportunities for global project delivery.
* Influence life‑changing healthcare technologies.
* Consultancy that values curiosity, integrity, collaboration.
Core Responsibilities
* Provide quality and regulatory support for Human Factors & Usability studies, Device Design & Development, and pre‑clinical & 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.
Qualifications
* Proven experience applying quality principles to Human Factors, Usability, Risk Management in line with ISO 13485, IEC 62366‑1, ISO 14971, and FDA guidance.
* Strong cross‑functional collaboration and stakeholder engagement skills.
* 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.
* Up‑to‑date with industry trends and best practices.
* Curious, collaborative, committed to making a difference.
Referrals increase your chances of interviewing at Crux Product Design by 2x.
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