Director Quality Systems

City: Ballerup

Country: Denmark

Business Area: Quality Assurance

Department: Global Quality Management

Employment Type: Full-time

Director Quality Systems

Are you excited by quality and compliance within the Medical Device industry? Are you a passionate people manager, keen to make your team grow and bloom? Do you want to be part of a pioneering Quality Management team, continuously setting the bar high in everything we do?

Then this might be your defining moment. Apply today and join us as Director of Global Quality Management Systems out of our HQ in Ballerup, Denmark or Augsburg, Germany.

Key responsibilities

In this role, you will lead a stellar team consisting of 10 talented QM (senior) professionals. Together, you will ensure quality and regulatory compliance of Ambu products and processes across the organization by continuously monitoring compliance.

This will include development and optimization of the Quality Management System and Processes within your team’s area of responsibility. Moreover, you will be accountable for the Audit Management globally.

Your main responsibilities will include:

• Daily manager of the Department Global QM Systems in Ambu
• Ensure a smooth change control process which is in compliance with regulatory requirements
• Implement effective global processes, with optimal balance between global and local responsibility
• Ensure a high degree of scalability, which means that the process of adding (or removing) sites covered by the Quality System can be done with a minimum of changes to the existing QMS
• Overall responsible for Global QMS Expert Forum, that identify and coordinate proactive solutions to global challenges to Ambu Quality Systems.
• Ensure monitoring of Global QMS system to ensure continued compliance and efficiency - and act when non-conformities are identified
• Ensure know-how center for quality management system issues, and ensure proper implementation through education and assistance to the organization
• Educate the organization on the importance of QM
• Ensure Internal Audit Plans and Corporate Audit Plans are executed, manage and participate in internal audit (audit coordination)
• Planning and leading of External audits. Contact to external auditors.
• Host and participate during inspections from authorities. Overall responsible for Corporate Quality Systems participation in Audits.
• Project management of selected projects within QMS area including integration and partnerships Global sales organization

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• Havea relevant academic background, BSc / MSc or higher
• Have at least 8-10 years’ experience of leading a quality organization within Medical Devices
• Have strong knowledge of relevant regulations for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MD
• Have a passion for quality and focus on QM business partnering with the organization

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development