Director of QA, Atos Medical, a part of Coloplast A/S

Do you want to work with improving current quality processes while ensuring high quality during the manufacturing of medical devices within the laryngostomy and tracheostomy area?

Join us to set the direction for 4 highly skilled and dedicated teams. You will have a lot of impact on how the teams operate individually and in collaboration as you ensure a unified approach to processes and collaboration.

Lead, motivate and improve ways of working for 4 important quality teams
You will be leading the QA Management team of Atos Medical, which consists of 4 senior managers who are leading different areas within QC, QA specialists and Sustaining Engineers. The teams are key when it comes to driving quality activities during the development of new innovative products. They are also responsible for the maintenance of technical files, complaint handling, validations, and other activities to maintain compliance of the medical devices that we place on the market. 

2 of the teams are based in Germany (Nieder-Olm), and the other 2 teams are located in Sweden (Hörby). The department consists of approximately 45 employees.

Joining us, you will be based in either Atos Medical in Hörby, Sweden, or in the Coloplast headquarters in Humlebæk, Denmark. You should expect to be working from Hörby a minimum of 2 days/week and the rest of the time at the headquarters in Humlebæk and in the site in Nieder-Olm, Germany. Therefore, you should expect to travel between locations regularly to meet with your teams.

 
“You’ll become part of the Compliance and Integration management in the Coloplast headquarters, influencing the direction of our global quality management processes, as well as being part of the site management in Hörby, Sweden and Nieder-Olm, Germany. You’ll be working with great and dedicated colleagues from all areas of the Coloplast organisation,” says Senior Director, Compliance & Integration Hassan Arrakha.

Create unity and closer collaboration
As a QA director, you will be working with integration activities, ensuring the improvement and integration of local quality processes to scalable Coloplast solutions. Together with your management team, you will align processes, ensuring deliverables by updating local procedures to comply with the corporate procedures. The goal is to have one Quality Management System. Furthermore, you will ensure deliverables to a “One IT infrastructure” initiative by getting the local organisations ready for the journey with the necessary documentation updates and training. 

You have solid people management experience, ideally within the medical device industry. It is a prerequisite that you are emphatic and have an affiliative leadership style, where you utilise your interpersonal skills to empower and motivate your employees and create followship in a changing environment.   

Today, the teams are well-established and well-functioning both individually and together; however, your task will be to take their cross-team collaboration even further. Creating an even higher level of synergy between the teams, you will work to foster a joint Coloplast feeling – while still respecting the individual team dynamics and culture. 

More specifically, your key tasks will be to:

• Manage and develop your employees
• Ensure efficient operational QA activities and support the R&D function
• Optimise, streamline and update QA processes in collaboration with teams and other stakeholders
• Represent QA in various SteerCos, influencing the site’s decisions and bridge to integration activities
•  Maintain documentation for legacy products
• Ensure progress in the finalisation of MDR activities
• Be one point of contact to Notified Bodies 

Stakeholder, change, and people management experience 
Stepping into this position, you will need to engage with stakeholders at all levels of the organisation. At the same time, you will need to have good communication skills and a solid process understanding. 

Also, you are known as an approachable leader with the ability to motivate and inspire your teams and stakeholders, mastering the art of creating unity while respecting and acknowledging individuality. 

Moreover, we imagine that you:

• Bring a degree in engineering, pharmaceutical science, or similar
• Have experience working with change management
• Have experience leading managers
• Have experience working with QA processes
• Speak and write English effortlessly

Interested?  
If you would like to know more about the position, please call Senior Director of Compliance & Integration Hassan Arrakha on +45 49 11 26 61. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found. 

Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox®, Provox Life™ and Tracoe.

We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business. 

Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma.

Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S

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