Quality Director

Role overview: 

This is a senior leadership position with full responsibility for shaping and driving the enterprise-level Quality Management System across both development and manufacturing operations. The role goes beyond operational quality—focusing on strategy, regulatory alignment, and business integration, while acting as a key member of the leadership team.

Key Responsibilities:

• Define and continuously evolve the company-wide Quality Management System aligned with business strategy.
• Establish and review policies, processes, and quality frameworks at organizational level.
• Lead the implementation of an integrated QMS software system.
• Define and monitor quality KPIs across the organization.
• Ensure full compliance with global regulatory frameworks (e.g. MDR, FDA).
• Interpret and implement regulatory requirements across development and manufacturing.
• Act as a primary interface with regulatory authorities, notified bodies, and relevant partners.
• Actively contribute to corporate strategy as a member of the leadership team.
• Provide strategic quality support to development and innovation processes.
• Design and oversee internal audit frameworks.
• Support partners in achieving compliance with standards such as ISO 13485.
• Lead, mentor, and develop the quality organization.
• Establish and oversee internal training and development programs.

Candidate profile:

• Degree in Engineering, Life sciences, or a related technical field.
• 10+ years of relevant experience in medical device development and manufacturing.
• Proven leadership experience in quality management within regulated environments.
• Deep expertise in ISO 13485 and FDA regulations.
• Strong understanding of MDR and global regulatory landscapes.
• Fluent English (written and spoken) is essential for international collaboration.
• Experience with QMS.
• Based in Hungary or open to relocation.

Place of work: Budapest area

What’s offered:

• Senior executive compensation package.
• Cafeteria benefits.
• Flexible working schedule.
• Hybrid setup (1 day/week home office).
• Ongoing professional development and training support.
• Opportunity to shape quality strategy in a dynamic, internationally connected organization.

Why this opportunity?

This role offers the chance to make a tangible strategic impact in a company where quality is deeply embedded in business success—providing both leadership visibility and long-term influence in a complex, regulated environment.

If this opportunity aligns with your experience and ambitions, we welcome your application via the button below!

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