Director of Quality Assurance (EMEA), Utrecht
Director of Quality Assurance (EMEA), Utrecht
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Utrecht, Nederland -
Geplaatst op: minder dan een week geleden
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Onthouden -
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Director of Quality Assurance, EMEA (Medical Devices)
I’m currently partnering with a leading international Medical Device organisation to appoint a Director of Quality Assurance, EMEA. A senior leadership role with full ownership of quality strategy, compliance, and QMS performance across the region.
This is a high-impact position where you’ll lead QMS, Supplier Quality, and Divisional QA teams, ensuring compliance with EU MDR 2017/745, ISO 13485, and global standards, while driving continuous improvement and operational excellence across multiple sites.
Key focus areas:• Leadership of regional Quality&Compliance strategy across EMEA• Oversight of QMS (CAPA, audits, change control, management review) • Supplier quality and finished goods compliance • Design controls, risk management (ISO 14971), and product lifecycle quality • Cross-functional collaboration with RA, R&D, Operations, and global stakeholders• Leading audits (Notified Bodies, authorities, customers) and regulatory readiness • Driving harmonisation and simplification of QMS across sites
What we’re looking for: • 10+ years in Medical Device Quality (Class I/II preferred) • Strong expertise in EU MDR, ISO 13485, and end-to-end QMS • Proven leadership experience across multiple teams and locations • Track record in building quality culture and influencing senior stakeholders• Strategic mindset with hands-on execution capability • Expertise with product development activities, including DHF, design controls..
Why consider this role? You’ll be joining a growing, globally connected business where quality is at the core of innovation and market expansion, offering real scope to shape strategy, lead transformation, and make a lasting impact.
Scope overview:€90–115k base (including 8% holiday allowance) 10% bonus, pension, and NS travel card
If this sounds like you (or someone in your network) feel free to reach out for a confidential discussion.
#MedicalDevices #QualityLeadership #QMS #RegulatoryAffairs #Hiring #EMEA
I’m currently partnering with a leading international Medical Device organisation to appoint a Director of Quality Assurance, EMEA. A senior leadership role with full ownership of quality strategy, compliance, and QMS performance across the region.
This is a high-impact position where you’ll lead QMS, Supplier Quality, and Divisional QA teams, ensuring compliance with EU MDR 2017/745, ISO 13485, and global standards, while driving continuous improvement and operational excellence across multiple sites.
Key focus areas:• Leadership of regional Quality&Compliance strategy across EMEA• Oversight of QMS (CAPA, audits, change control, management review) • Supplier quality and finished goods compliance • Design controls, risk management (ISO 14971), and product lifecycle quality • Cross-functional collaboration with RA, R&D, Operations, and global stakeholders• Leading audits (Notified Bodies, authorities, customers) and regulatory readiness • Driving harmonisation and simplification of QMS across sites
What we’re looking for: • 10+ years in Medical Device Quality (Class I/II preferred) • Strong expertise in EU MDR, ISO 13485, and end-to-end QMS • Proven leadership experience across multiple teams and locations • Track record in building quality culture and influencing senior stakeholders• Strategic mindset with hands-on execution capability • Expertise with product development activities, including DHF, design controls..
Why consider this role? You’ll be joining a growing, globally connected business where quality is at the core of innovation and market expansion, offering real scope to shape strategy, lead transformation, and make a lasting impact.
Scope overview:€90–115k base (including 8% holiday allowance) 10% bonus, pension, and NS travel card
If this sounds like you (or someone in your network) feel free to reach out for a confidential discussion.
#MedicalDevices #QualityLeadership #QMS #RegulatoryAffairs #Hiring #EMEA
Belangrijke informatie
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BedrijfsnaamPanda International -
PositieDirector of Quality Assurance (EMEA)
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