QA Manager Site Denmark, Global Quality
Core
Leading a team of QA engineers to ensure quality and regulatory compliance in manufacturing processes for in vitro diagnostic medical devices.
Role type
Senior Manufacturing QA Manager
Builds
Qualified and validated manufacturing processes, equipment, and test methods for cancer diagnostic devices
Domain
Medical Devices / In Vitro Diagnostics / Manufacturing Quality
Required skills
People leadership, Change Control management, Risk management, Audit readiness, Strategic project leadership, Compliance with EU IVD Regulation and ISO 13485
Preferred skills
Hiring and coaching, Performance management, Succession planning
Technologies
ISO 13485, FDA 21 CFR part 820, MDSAP, IVDR, Agilent QMS
Responsibilities
Lead and develop the Manufacturing QA qualification and validation team; Partner with Manufacturing division to align priorities and enable project deliveries; Represent QA management in strategic projects; Participate in and lead internal and external audits; Ensure compliance with relevant standards and regulations; Manage the Change Control process; Ensure inspection and audit readiness.
Seniority
Senior, hands-on IC with people management