Job type
TemporaryLocation
MacclesfieldWorking Pattern
Full-timeSpecialism
Quality Assurance And ValidationIndustry
PharmaceuticalsPay
Day RateClosing date
20 Mar 2026
AZ are currently seeking an interim medical device QMS lead for an initial 6-month assignment.
Title:
Device Quality Management Systems Lead
Device Quality Management Systems Lead
Duration:
6 months
6 months
Location: Macclesfield, UK (Hybrid Working)
IR35 Status:
Outside
Outside
Role Overview
A Quality professional with significant subject expertise in Medical Device and Combination Products quality system requirements.
Leads initiatives that build and ensure continuous improvement, optimization and maintenance activities of the device life cycle processes, partnering to ensure other interface processes include relevant device requirements.
This role sits within the Global Device Quality team who ensure end-to-end delivery of safe and effective devices from development through to our patients.
Accountabilities
- Enhance our Quality Management System processes
- Draft / enhance global procedures to strengthen the processes for Medical Devices
- Provide subject matter expertise and coaching
- Facilitate sharing and adoption of good practices & learning
- Identify, calibrate and manage risks, escalate as required
- Provide expert knowledge in interpreting device legislation, regulation and guidelines.
- Lead cross-functional workstream teams to create / update quality process content
- May provide SME support for audit preparation
Essential Requirements:
- Bachelor’s degree in engineering or equivalent technical discipline
- Demonstrated experience in quality system process creation and management in a regulated environment.
- Significant Subject Matter Expertise in device design life cycle and risk management requirements (specifically ISO13485, EU MDR, 21 CFR Part 820, ISO 14971)
- Strong understanding of the PRRC (Person responsible for Regulatory Compliance) role under the EU MDR.
- Demonstrated track record of successful delivery within a matrix organization
Desirable Requirements:
- Device product-facing experience across the design, development and on-market life cycle.
- Knowledge of EU IVDR, IEC 62304 and Medical Device software development.
- Practical implementation of Medical Device requirements within a pharmaceutical company.
- MDSAP / ISO 13485 audit readiness preparation
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
For more detailed information, or to view other vacancies with this organisation, please visit our dedicated recruitment website https://webmicrosites.hays.co.uk/web/tempwork_astrazeneca
