Head of Quality
Your Responsibilities
Lead the Quality department for our Sutures product line across our two facilities.
Ensure full compliance with key regulatory frameworks such as MDR 2017/745, ISO 13485, MDSAP, FDA QSR, and other applicable global standards.
Oversee the implementation and continuous enhancement of the Quality Management System (QMS), including CAPA processes and internal audits.
Translate international regulatory and quality standards into product-specific requirements and practical application.
Track and interpret global quality and compliance trends, offering strategic insights to internal stakeholders.
Act as the designated quality lead across both sites, serving as the primary point of contact for all quality-related matters.
Provide both technical direction and people leadership to the local quality teams at each site.
Your Profile
University degree in industrial engineering, quality management, or a related field.
Minimum of 8 years' experience in quality roles within a manufacturing environment, including at least 3 years in a leadership position.
Strong understanding of international quality and regulatory standards, particularly MDR, FDA QSR, and ISO 13485.
Hands-on experience managing customer complaints, quality investigations, and internal quality assurance initiatives.
Excellent communication skills in German and English - both written and spoken.
Skilled in managing supplier quality and maintaining production-level quality assurance.
What We Offer
A strategic leadership position in a rapidly growing international company shaping the future of medical technology.
Competitive salary package with flexible working arrangements.
A flat organizational structure and collaborative team culture.
Tailored development programs and continuous learning opportunities.
The chance to help design cutting-edge medical products that have a tangible impact on patient lives.
FAQs
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