Quality Assurance Lead
Posted 1 day ago by AstraZeneca
Negotiable
Outside
Hybrid
Macclesfield, England, United Kingdom
Summary: The Device Quality Management Systems Lead is a pivotal role focused on enhancing quality management systems for medical devices and combination products. This position involves leading initiatives for continuous improvement and ensuring compliance with relevant regulations throughout the device life cycle. The role requires collaboration with cross-functional teams to optimize processes and provide subject matter expertise in quality systems. The position is based in Macclesfield, UK, and operates in a hybrid working environment.
Key Responsibilities:
- Enhance Quality Management System processes.
- Draft and enhance global procedures for Medical Devices.
- Provide subject matter expertise and coaching.
- Facilitate sharing and adoption of good practices and learning.
- Identify, calibrate, and manage risks, escalating 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.
Key Skills:
- 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 role under the EU MDR.
- Demonstrated track record of successful delivery within a matrix organization.
- Device product-facing experience across the design, development, and on-market life cycle (desirable).
- Knowledge of EU IVDR, IEC 62304, and Medical Device software development (desirable).
- Practical implementation of Medical Device requirements within a pharmaceutical company (desirable).
- MDSAP / ISO 13485 audit readiness preparation (desirable).
Salary (Rate): undetermined
City: Macclesfield
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Title: Device Quality Management Systems Lead
Duration: 6 months
Location : Macclesfield, UK (Hybrid Working)
IR35 Status: 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