QUALIFICATIONS

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Minimum 5 years’ experience in Quality Assurance within a regulated distribution or manufacturing environment.
• At least 3 years in a leadership role managing quality professionals in a multi-site or matrixed organization.
• Proven track record in implementing and maintaining ISO 13485 or equivalent QMS.
• Experience with EU MDR, MDSAP, GMP, and relevant international standards.
• Proficiency in structured problem-solving (A3, 8D, DMAIC) and data-driven decision making.
• Strong influencing skills with the ability to manage priorities in complex environments.
• Excellent communication skills, with the ability to present effectively to senior leadership.

ABOUT THE ROLE

We are looking for an experienced and forward-thinking QA Manager to lead quality operations across our EMEA distribution network. This role is critical in ensuring the implementation, maintenance, and continuous improvement of a robust Quality Management System (QMS) in a multi-site, regulated environment.
Reporting into the global quality function, you will act as a strategic partner to Operations, Supply Chain, Regulatory, and Corporate Quality teams, fostering a culture of compliance, excellence, and continuous improvement. You will ensure alignment with ISO 13485, EU MDR, and other global regulatory standards while driving quality initiatives across the region.

KEY RESPONSIBILITIES

• Provide strategic leadership for quality activities across multiple distribution centers in the EMEA region.
• Act as a trusted advisor to site stakeholders, ensuring strong cross-functional alignment.
• Champion a proactive, quality-first culture to drive operational excellence.
• Lead initiatives to simplify, standardize, and improve QMS processes.
• Allocate team resources to support quality, delivery, and cost objectives.
• Monitor and report on quality performance, risks, and improvement opportunities to senior leadership.
• Ensure audit readiness and compliance with ISO 13485, EU MDR, MDSAP, and other applicable standards.
• Oversee investigations, CAPA processes, and non-conformance management using structured problem-solving methodologies (A3, 8D, DMAIC).
• Identify and address systemic quality risks through data analysis and root cause investigation.
• Lead and develop a geographically dispersed quality team, fostering engagement, accountability, and high performance.
• Collaborate with global quality, regulatory, and supply chain counterparts to ensure alignment.
• Support integration projects that enhance efficiency and compliance within the supply chain.