Do you confidently navigate complex global regulatory environments and translate them into business value?
Have you successfully aligned quality, R&D, and manufacturing within a highly regulated industry?
Would you like to shape not only internal systems, but also influence quality standards across international partnerships?
If so, this opportunity may represent your next leadership challenge!
We are partnering with a well-established, innovation-driven company operating in the medical device development and manufacturing sector. The organization serves as a trusted partner to international clients, supporting complex development and production projects in a highly regulated environment.
To support its continued growth and strategic ambitions, we are seeking a highly experienced and forward-thinking:
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!
