Director of Quality Management

Job summary

This role involves leading the Quality Competence Centre, an international organization focused on quality management in the medical device industry. The position is based in Humlebæk and requires strategic decision-making to enhance innovation and ensure patient safety.

Qualifications

• Extensive experience in Quality Management
• At least 5 years of experience in people management, including leading managers
• Background in the medical device industry or another highly regulated sector
• International experience managing teams across multiple countries
• Fluent in written and spoken English
• Familiarity with medical device quality systems and global regulatory frameworks such as ISO 13485, EU MDR, and FDA regulations is advantageous.

Responsibilities

• Lead the Quality Competence Centre across Denmark, Hungary, and Poland through three direct-report managers
• Set the strategic direction for Sterilization, Microbiology, Supplier Quality, Biosafety, and Chemical Compliance
• Conduct supplier quality management reviews in collaboration with Direct Procurement
• Ensure resources are available for internal and external audits while monitoring and reporting departmental performance
• Engage and mobilize stakeholders across R&D, Operations, Procurement, and Regulatory Affairs to align on quality objectives
• Challenge existing processes to simplify decision-making and enhance quality as a strategic enabler of innovation

Skills

• Strong leadership and motivational skills
• Ability to inspire teams through change
• Proficient in building relationships and creating alignment among diverse stakeholder groups
• Strategic thinking and effective execution of key decisions

Education

• Relevant degree in a related field (not specified in the description)

Tools

• Experience with quality management systems and regulatory compliance tools relevant to the medical device industry.