Quality Specialist

Contract: 32-40 hours per week, temporary (12 months)
Department: Quality and Regulatory Affairs
Location: Varsseveld, The NL

Who we are

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 Netherlands (currently Arnhem; to be moved to Utrecht in 2025). To learn more about Medline’s operations in Europe, visit www.medline.eu.

Purpose

In this temporary QA Manager role within our Dutch Operations team and play a key role in managing and maintaining our Quality Management System (QMS) for Healthcare Surgical products, ensuring compliance with ISO 13485, EU Medical Device Regulation [EU 2017/745], FDA requirements and notified body standards. 

The Dutch operations comprise of the manufacturing activities in Varsseveld and sales support, warehousing and European distribution of Class I and Class IIA medical Devices in Zutphen. You will be promoting the awareness of customer requirements throughout the organization, support the supply chain in acute quality issues and be the quality representative in ongoing projects and improvements

How can you help us?

• Lead and maintain the QMS aligned with ISO 13485 and FDA 21 CFR Part 820
• Manage the QA department’s budget and resources
• Support regulatory technical files and product registration processes
• Coordinate risk management, internal audits, complaint investigations, and quality projects
• Supervise and develop a small QA team
• Manage external audits and ensure compliance with quality standards
• Oversee product release and batch documentation processes
• Collaborate with cross-functional teams and external partners to resolve quality issues
  

Are you a match?

• Bachelor’s degree in science, Engineering, Management, or equivalent (Dutch HBO level preferred)
• Several years of experience in medical device manufacturing or similar industry, preferably certified according to EN ISO 13485
• Experience in (medical) device product and process validations
• Strong knowledge of ISO 13485, Medical Device Regulation, and FDA 21 CFR Part 820
• Experience with sterilisation and medical device manufacturing is a plus
• Proficient in English
  

What we offer

• 12-months contract (part-/or full-time)
• Market related salary and a bonus plan
• A range of training opportunities
• Employee Assistance Program
• 29 vacation days
• Hybrid working options
• International working environment

Ready for a new challenge?

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.

Contact

Please apply before 4 August by submitting your resume below.