Medline is a leading provider of medical-surgical products and supply chain solutions, serving all points of care. Through a wide-ranging product portfolio, a robust supply chain network and modern clinical solutions, Medline helps healthcare providers (HCPs) improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, United States, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. Outside the US, Medline International B.V. serves as the international headquarters and is located in the Utrecht Netherlands. To learn more about Medline’s operations in Europe, visit www.medline.eu.
As part of the Medline EMEA QARA Team, this role is responsible for leading Quality Compliance for Medline EMEA, ensuring all finished goods, supplier quality aspects, and Quality Management System (QMS) operations meet the requirements of EU MDR 2017/745, ISO 13485, and corporate standards.
Maintain and continuously improve the Medline Europe Quality Management System (QMS) in alignment with ISO 13485, ISO 9001, and EU MDR 2017/745.
Ensure all finished goods meet applicable regulatory and quality requirements before market release.
Oversee and manage design control activities to ensure compliance with ISO 13485, MDR, PPE Regulation, Cosmetics Regulation, and other relevant standards.
Collaborate with Divisions, Engineering, and Regulatory teams to manage new product launches and design change projects, ensuring efficient and compliant market access.
Ensure product development documentation and Design History Files (DHFs) comply with regulatory and corporate standards.
Ensure risk management activities are compliant with ISO 14971 and integrated throughout the design and development process.
Oversee product testing activities and ensure compliance with EU and internal testing requirements.
Lead, mentor, and develop Divisional QA, QMS, and Supplier Quality teams, fostering a culture of accountability, compliance, and continuous improvement.
Define and monitor team goals, objectives, and performance metrics aligned with business and regulatory requirements.
Oversee document control, training, CAPA, change control, and management review systems.
Facilitate, plan and organize internal and external audits from customers, notified bodies, and competent authorities.
Ensure the CAPA process is effective and managed in a timely manner from initiation to closure.
Support Regulatory Affairs in providing quality documentation for Technical Files and product registrations.
Identify, lead, and implement process improvement initiatives to enhance efficiency, compliance, and product quality.
Monitor and report QMS performance and quality metrics through defined KPIs and management reviews.
Lead QMS harmonization and simplification initiatives across EMEA sites.
Increase quality awareness across the organization by promoting ownership, training, and engagement at all levels.
Drive supplier quality compliance with ISO 13485, EU MDR, and corporate quality procedures in close collaboration with Global Sourcing Organization (GSO).
Collaborate with Sourcing and Procurement to manage supplier risk, approval, and escalation pathways.
Support mergers and acquisitions by performing quality due diligence and integrating acquired sites into the corporate QMS.
Collaborate closely with Manufacturing QA, Regulatory Affairs, R&D, Engineering, Operations, and US/Asia counterparts to align compliance and business priorities.
Develop strategic quality roadmaps and resource plans to support company growth and market expansion.
Establish measurable KPI frameworks for Finished Goods, QMS, and Supplier Quality, ensuring targets are met and actions taken when off-track.
Serve as Quality representative in corporate initiatives, audits, and cross-functional projects.
Promote a proactive culture of compliance, risk awareness, and operational excellence.
Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related technical field.
Minimum 10 years of experience in medical device quality assurance.
Excellent knowledge of ISO 13485, EU MDR 2017/745, MDD 93/42/EEC, and related regulatory frameworks.
Proven expertise in design controls, risk management, CAPA, QMS and quality compliance.
Demonstrated ability to lead, coach, and develop teams across multiple locations.
Strong leadership and influencing skills, with the ability to inspire collaboration across functional and geographic boundaries.
Excellent communication and interpersonal skills across multiple cultures and levels of seniority.
Strong organizational and analytical skills, with a focus on data-driven decision-making.
Demonstrated commitment to continuous improvement and operational excellence.
Proactive, adaptable, and resilient approach, able to navigate change in a fast-paced environment.
Proven problem-solving mindset with strong accountability and ownership.
Ability to work collaboratively across regions and cultural contexts, managing complex global quality operations.
Ability to travel across Europe to support teams and sites.
Medline thrives when everyone feels truly connected and empowered to contribute their unique insights. We aim to ensure an environment where every individual feels a strong sense of belonging and is fully engaged. We're eager to welcome applicants, regardless of background and/or lived experiences, recognising that our differences in perspectives enables us to carry out our mission to help improve healthcare delivery and outcomes. We look forward to receiving your application.
