Department: Quality Assurance and Regulatory Affairs

Role reports to: Microtek Medical EU Quality Manager

Location: Zutphen, The Netherlands

As part of the EU Medline/Microtek QA Team, this role supports the Microtek Medical BV and Malta (« EU MM ») products and reports to the Microtek EU Quality Assurance Manager. Based in Zutphen, Netherlands, the QA Lead is responsible for the quality assurance activities such as maintenance of quality management systems (QMS) documentation related to warehousing and distribution, as well as complaint handling, product control, and finished goods release.

How can you help us?

• Oversee the QA Team based in Zutphen, NL.
• Manage the implementation and maintenance of the Zutphen QMS (i.e. document control, employee training, corrective and preventive action, deviation, non-conforming product).
• Facilitate internal and external audits (ISO 13485, ISO 14001, other warehouse certifications and licenses, as applicable).
• Oversee incoming inspection activities.
• Oversee the release of finished goods post sterilization (ETO, Gamma);
• Troubleshoot sterilization issues and provides sterilization project support.
• Support complaint handling and investigation activities.
• Administer and manage site employee training, as applicable.
• Manage the handling of customer questionnaires and agreements.
• Oversee control of non-conforming product within the warehouse, and performs activities related to product hold, repack/rework and product inspection activities; and
• Perform regular Warehouse Quality Checks and prepares reports.
• Experience in leading a team. 

Are you our match?

• A HBO or university degree with 2+ years of work experience, preferably in a regulated industry such as medical devices, pharmaceuticals, or other biotechnology sector;
• Knowledge of ISO 13485, European Good Distribution and Warehouse Practices.
• Knowledge of ISO 14001 is preferred.
• Experience working in a warehouse is preferred.
• Dependable, self-driven and works autonomously with a strong sense of urgency.
• Proven ability to work collaboratively across functional departments.
• Excellent written and oral communication skills Dutch; fluency in English is required.
• Good communication/organizational skills with the ability to build and maintain a strong relationship with internal stakeholders.  

We have everything covered

• A comprehensive introduction by experienced colleagues - An individually tailored onboarding plan and fixed contacts so you can be off to a great start.
• Company pension plan - We increase our contributions to your pension plan throughout your employment because setting you up for a successful retirement is important to us.
• 26 days of vacation – We also focus on personal development
• A range of training opportunities - We actively support you in your professional development
• Fresh fruit, free coffee, bi-weekly team lunch and other benefits, such as Medfit Wellness Centre - So that your physical well-being is taken care of
• Employee Assistance Programme – So that your mental well-being is taken care of
• Flexible working options - To make your work flexible and productive
• International working environment - Our European headquarters is truly diverse.

Medline is committed to reducing our carbon footprint, developing responsible products, supporting our employees and local communities, and promoting high ethical standards internally and among our supplier partners. Click here to discover what Medline is doing to make healthcare more sustainable for people and the planet.