We are partnering with a leading international medical device organization with a strong global presence in women’s health and advanced healthcare technologies. The company’s diverse portfolio includes innovative medical devices, testing solutions, and patient care products distributed worldwide.
About the Role
We are seeking a Director of Quality to oversee Quality operations for the company’s European Distribution Center, located in the Leiden area. This is a high-impact leadership role with responsibility for ensuring regulatory compliance, driving strategic improvements, and aligning local operations with global quality standards. You will lead a small local team while influencing cross-functional and regional stakeholders across EMEA and APAC.
Key Responsibilities
- Provide overall leadership for Quality within the Distribution Center, ensuring full compliance with ISO 13485, MDR/IVDR, FDA, and other relevant regulations.
- Define and execute strategic quality objectives for the site in alignment with global and regional business priorities.
- Drive a culture of quality, regulatory compliance, and continuous improvement across distribution and supply chain operations.
- Oversee and strengthen the Quality Management System, ensuring robust processes for CAPA, deviations, change control, complaints, and audits.
- Act as the senior point of contact for health authority and notified body inspections, leading audit preparation, execution, and close-out.
- Collaborate with global and regional Quality and Regulatory leaders to ensure alignment and consistency across sites, including satellite distribution centers in EMEA and APAC.
- Develop, mentor, and coach the local Quality team, fostering professional growth and high performance.
- Report key quality metrics and insights to senior leadership, ensuring visibility and accountability at regional and corporate level.
Qualifications
- MSc or higher degree in Science, Engineering, Pharmacy, or a related discipline.
- 10+ years of experience in Quality, Regulatory, or Compliance roles within medical devices, pharmaceuticals, or other regulated industries.
- At least 7 years in leadership positions, with proven ability to influence at regional/global level.
- Strong expertise in ISO 13485, MDR/IVDR, GMP, GDP, and GSP practices.
- Successful track record of managing audits and driving CAPA implementation.
- Experience working in multinational organizations with complex supply chains.
- Fluent in English (spoken and written); additional European languages are an advantage.
- Strategic mindset with strong stakeholder management and communication skills.
What’s on Offer
- Senior leadership role in a global, fast-growing medical device organization.
- High visibility to regional and corporate executives, with influence across EMEA and APAC.
- Opportunity to shape strategy, strengthen compliance, and lead continuous improvement at a critical European hub.
- Onsite, collaborative environment.
To apply or discuss this opportunity, please send your CV to c.ruiz@panda-int.com