Title:
Device Quality Management Systems LeadDuration:
6 monthsLocation: Macclesfield, UK (Hybrid Working)IR35 Status:
OutsideRole OverviewA Quality professional with significant subject expertise in Medical Device andbination 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
1. Enhance our Quality Management System processes
2. Draft / enhance global procedures to strengthen the processes for Medical Devices
3. Provide subject matter expertise and coaching
4. Facilitate sharing and adoption of good practices & learning
5. Identify, calibrate and manage risks, escalate as required
6. Provide expert knowledge in interpreting device legislation, regulation and guidelines.
7. Lead cross-functional workstream teams to create / update quality process content
8. May provide SME support for audit preparation
Essential Requirements:
9. Bachelor’s degree in engineering or equivalent technical discipline
10. Demonstrated experience in quality system process creation and management in a regulated environment.
11. Significant Subject Matter Expertise in device design life cycle and risk management requirements (specifically ISO13485, EU MDR, 21 CFR Part 820, ISO 14971)
12. Strong understanding of the PRRC (Person responsible for Regulatorypliance) role under the EU MDR.
13. Demonstrated track record of successful delivery within a matrix organization
Desirable Requirements:
14. Device product-facing experience across the design, development and on-market life cycle.
15. Knowledge of EU IVDR, IEC 62304 and Medical Device software development.
16. Practical implementation of Medical Device requirements within a pharmaceuticalpany.
17. MDSAP / ISO 13485 audit readiness preparation