Director, Quality Assurance EMEA - #48439

Are you passionate about elevating quality standards and making a real impact in healthcare? Do you thrive on leading diverse teams and driving strategic initiatives across international markets?

As the Quality Director for Hologic EMEA, you will serve as the Quality Management Representative for the region, providing strategic leadership for the Quality Management System across EMEA. You will ensure compliance with global and regional regulations, drive continuous improvement, and champion a customer-focused culture. You will also play a pivotal role in supporting the standardization and future expansion of Hologic’s international quality systems.

What to expect:

• Lead & Inspire: Guide and mentor our talented EMEA Quality team, fostering growth, high performance, and cross-border collaboration.
• Quality Champion: Ensure our QMS aligns with ISO 13485, 21 CFR, MDR/IVDR, UK CA Marking, and all relevant regulations—making compliance second nature.
• Strategic Partner: Collaborate with Regulatory, Operations, R&D, Supply Chain, Legal, and Commercial teams to drive quality objectives and harmonize processes.
• Continuous Improvement: Lead Lean, Six Sigma, and data-driven initiatives to manage non-conformances, CAPAs, complaints, and post-market surveillance.
• Voice of the Customer: Embed a customer-centric mindset across the organization, ensuring customer needs are the foundation of every quality activity.
• Regulatory Interface: Act as primary contact for regulatory authorities, notified bodies, and auditors throughout EMEA.
• Talent Developer: Assess organizational structure, address skill gaps, and coach team members to build a world-class quality function.
• Risk Manager: Proactively identify and mitigate quality risks, staying ahead of regulatory changes and industry best practices.
• Training & Development: Provide annual training on GMP/audit readiness
  
  

What we expect:

Experience: Proven expertise in medical device quality management, with deep knowledge of EMEA regulations and standards (ISO 13485, 21 CFR, MDR/IVDR).

Education: Bachelor’s degree in engineering or a related field required; Master’s (MBA, Quality Management, Engineering) highly preferred.

Leadership: Demonstrated success managing large, diverse teams across multiple countries and cultures

Skills: Analytical and strategic thinker. Strong problem-solving and decision-making abilities. Excellent communicator and influencer at all levels. Ability to drive accountability and empower others

Behaviours: Collaborative and effective in a global, matrixed environment. Champion for continuous improvement and a culture of quality. Promoter of accountability and team empowerment

Partnership: Maintain a working knowledge of Hologic's prodicts, and other responsibilities as assigned

Languages: Fluency in English required; additional languages a plus.

Travel: Willingness to travel across the EMEA region as needed ~15%.

Why Join Hologic?

• Make a Difference: Impact millions of lives by ensuring the highest standards in women’s health and diagnostics.
• Grow Your Career: Thrive in a global, innovative, and supportive environment.
• Drive Change: Be part of a company that values your ideas, expertise, and leadership.
  
  

Ready to make your mark? Apply now to lead quality excellence at Hologic!