Senior Director, Global Quality Assurance

Ambu A/S is currently looking for strong leader to head up the global Quality Assurance to be based out of our HQ in Ballerup, Copenhagen.

As the globally responsible for our QA function, you will play a pivotal role within our Senior management team, contributing to company strategy development, planning, and execution. You will lead the global QA strategy, ensuring ongoing compliance with regulatory requirements and standards. This role reports directly to the Chief Operating Officer.

The global QA team consists of almost 200 employees, 40 of which located in our HQ in Ballerup with solid reporting line into this position. The remaining are based in our 4 Manufacturing Sites in Penang, Xiamen, Ciudad Juárez and Noblesville. It is therefore essential that you both have experience in, and are passionate about, developing a high performing team through high levels of empathy and engagement and are able to set the global direction and create alignment and collaboration for Quality Assurance across Ambu through your leadership team consisting of both HQ and manufacturing sites. 

Additionally, this role will give you the opportunity to position the Quality Assurance function as a highly respected advisory function to other business areas including, but not limited to, Sales and R&D. Quality is essential in everything we do at Ambu, and it will be your role to drive the support beyond the legal requirements to bringing our ways of working above that of our competitors.
 

Key responsibilities

You will be mainly be expected to own the following responsibilities:

• Global QA Strategy and Leadership:
  • Develop and implement a comprehensive QA strategy, setting the direction for future goals and ambitions.
  • Manage, lead, and mentor the QA organization, fostering a collaborative and efficient work environment.
  • Streamline and optimize workflows within and across teams to enhance operational efficiency.
  • Drive continuous improvement initiatives to enhance quality systems and processes.
  • Participate in and support our innovation process in close collaboration with our R&D organization
  • Ensure QA oversight activities of Ambu sites – including our manufacturing sites 
  • Define and ensure adequate internal reporting on relevant quality metrics and ensure that continuous global Quality Management Reviews are conducted.   

• Quality Management System and certifications activities:
  • Develop and implement policies and Quality Management System processes to ensure continuous compliance with applicable regulatory requirements and standards, including EU MDR, ISO13485, MDSAP and UK MDR – in close collaboration with our RA leadership
  • Lead successful notified Body audits and inspections from competent authorities to continuously ensure compliance and maintain Ambu’s certifications, drawing on extensive experience in this area.

• Business Risk Management and Contingency Planning:
  • Identify and mitigate quality-related risks, developing alternative courses of action.
  • Anticipate suitable actions through scenario planning and develop effective contingency plans.
  • Product Lifecycle Quality Oversight: Anticipate and address quality-related obstacles and emerging issues throughout the product lifecycle.

• Inspections and Audits:
  • Ensure internal and corporate audit planning as well as audit execution across Ambu sites 
  • Ensure that corrective action plans and follow-up activities related to audits and inspections by competent authorities are provided promptly and accurately.

• Customer Complaint handling: Ensure timely handling of customer complaints and provide input for regulatory decisions of market actions when required 

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 have the following:

• Proven leadership experience with QA preferably within the Medical Device industry.
• High level of EQ and the ability to drive change through empathy, communication and inspiration
• In-depth knowledge of EU MDR, ISO13485, MDSAP and UK MDR.
• Demonstrated success in leading organizations through successful Notified Body audits and inspections by various competent authorities.
• Strong track record in streamlining and optimizing quality systems and processes.
• Experience of working in an international organization
• Excellent communication skills in English
• Previous experience working in a highly matrixed environment

 
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.