Senior Manager, Quality Assurance

Medline Europe

Sr. Manager of Quality Assurance overseeing compliance and quality standards for medical devices in Europe.

Posted 6/6/2026full-timeUtrecht • 🇳🇱 NetherlandsSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

ISO 13485EU MDR 2017/745MDD 93/42/EECdesign controlsrisk managementCAPAQMSquality complianceproduct testingregulatory documentation

Soft Skills

leadershipcoachingteam developmentcommunicationinterpersonal skillsorganizational skillsanalytical skillsproblem-solvingadaptabilitycollaboration

Certifications

Bachelor’s degree in Life SciencesMaster’s degree in EngineeringISO 13485 certificationEU MDR certification