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!
A jelentkezéssel elfogadod a Beck and Partners Kft. [Kattintson a weboldal linkjének megjelenítéséhez].