Quality Engineer (Compliance)

Job Title: Quality Engineer (Compliance) – Medical Devices

Location: Cambridge, UK (Hybrid)

Job Type: Contract

About the Project

A global biopharma organisation is expanding its Devices Centre of Excellence in Cambridge, UK. We are seeking an experienced contract Quality Engineer (Compliance) to support advanced medical device and drug–device combination product programmes. This is a hands-on, consultative contract role embedded within product development teams, ensuring design controls and risk management activities are completely audit-ready across the lifecycle from early development to clinical supply.

Key Responsibilities & Measurable Goals

Design Controls & Risk Management (Target: 100% compliance across DHF/RMF deliverables)

* Lead design control and risk management activities for assigned programmes, ensuring deliverables are accurate, approved, and maintained.

* Support and facilitate risk management workshops with external design and manufacturing partners.

* Provide quality engineering input into design validation activities, including Human Factors Engineering (HFE) and usability assessments.

Regulatory Compliance & Auditing (Target: Zero major audit non-conformances)

* Ensure strict compliance with key standards and regulations, including ISO 13485, ISO 14971, 21 CFR 820, and EU MDR.

* Assess external partners and suppliers for QMS capability, compliance, and regulatory readiness.

* Support root-cause investigations into device issues arising from clinical trials and contribute quality content to regulatory submission documentation.

Key Requirements & Qualifications

* Experience: 2+ years of contract or permanent experience focusing on medical devices or combination products within a strictly regulated environment.

* Technical Mastery: Practical experience creating, reviewing, and maintaining Design History Files (DHF) and Risk Management Files (RMF).

* Standards & Regulations: Working knowledge of ISO 13485 / ISO 14971 / 21 CFR 820 / EU MDR with the ability to apply them pragmatically to moving deadlines.

* Education: BSc/MSc/PhD in a relevant science or engineering discipline.

* Work Authorisation: Must possess valid right to work in the UK for contract assignments.

Nice to Haves

* Familiarity with EN 62366, EN 60601, or EN 62304.

* Good understanding of GMP principles