Senior Manager, Quality Assurance

Role Overview

• 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.

Requirements

• 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.

Benefits

• Market related salary and a bonus plan
• A range of training opportunities
• Employee Assistance Program
• Hybrid working option
• International working environment
• Additional benefits tailored to the local market