Lead our global team of Design Control Specialists

Ambu A/S is looking for a Manager for our global team of Design Control Specialists to be based out of our HQ in Ballerup, Denmark. 

 

Do you have experience with Design Control within a Medical Devices company? Do you thrive in optimizing the way things are done and  aligning with stakeholders across the business? Do you want to play a pivotal role in ensuring the quality and compliance of our medical device design and development processes?

 

Then you might be our new Innovation Process Manager. Apply today and join us for a career #ForeverForward!

 

Key responsibilities 

 

In this role you will manage a global team of specialists across three sites (DK, DE and MY). With the team, you will be responsible for managing and enhancing the design-control processes, collaborating and aligning across the organization, and driving continuous improvement initiatives to maintain and mature our standards for product development. 

 

We expect you to optimize our design- and development processes whilst ensuring efficient ways of working. As Innovation Process Manager you interact within both our Quality Management System and general business processes. With your team, you play an important role in ensuring that our processes are supporting efficient development of our market-leading product portfolio.  

 

Your main responsibilities will include: 

• Design Control Oversight: Lead the development, implementation, and maintenance of R&D design- control processes in compliance with regulatory requirements (FDA, ISO, etc.). 
• Process Improvement: Identify opportunities for process improvements and lead initiatives to enhance efficiency, effectiveness, and compliance within the design control and process framework 
• Project support: Support the projects in following the processes and support preparation of design control documentation in innovation projects 
• Audit Preparation: Prepare and support internal and external audits related to R&D processes. Implement corrective and preventive actions as needed. 
• Cross-functional Collaboration: Work closely with stakeholders within R&D, Quality Assurance, Regulatory Affairs, and other relevant departments to align on best practices and implement regulatory requirements throughout the product lifecycle. 
• Training and Development: Provide guidance and training to cross-functional teams on design control processes, ensuring a thorough understanding of regulatory requirements and adherence to internal policies. 
• Problem solving in relation to NCRs, CAPA across R&D 

 

Suggested candidate profile 

 

Skills and experiences can be earned in many different ways. You are however likely to succeed in this position if you: 

• Master's degree in engineering, Biomedical Sciences, or a related field - your experience and drive is what truly interests us 
• Minimum five years of experience in design control and process management within the MedTech industry. 
• Understanding of Quality Management Systems, FDA, ISO standards (ISO 13485), and other relevant regulatory requirements. 
• Strong process, project management and organizational skills. 
• Excellent communication and stakeholder-management skills. 
• Pragmatic approach to solving problems and maturing process and design control 
• Experience with project and/or people management across geographical sites 

 

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.