Risk Management and Design Control Specialist (12-months position)

 
Would you like a job where you are responsible for Risk Management for our Medical Devices and ensure compliance with our Design Control Procedures? – You will support our Lifecycle Projects as the Risk Management and Design Control Specialist. Together with a department of skilled and committed specialists you will maintain our Continence and Bowel Care products, ensuring safe and well-performing products that truly make a difference for people with intimate health care needs all around the world.

 
Then come join us! We are currently looking for a Risk Management and Design Control Specialist, for a 12-month position with the potential for extension.

 
“Taking ownership of the risk management of our devices and ensuring compliance to our design control process, you get to combine your specialist knowledge with project coordination. Work never gets dull. Each project presents unique tasks and questions,” says Henrik Edvardsen, Head of Lifecycle Management (LCM) Continence and Bowl.

 
Be part of a competence centre
In Global Quality, Regulatory Affairs and Sustainability, you will find our department, combining skills from across the organisation to work on maintaining the lifecycle of product specification and performance, product safety and design control. You will join the LCM CC & BC team consisting of 4 Risk Managers and Design Control Specialists and of 5 Product Support Specialists. We are located in Humlebæk Denmark and In Tatabanya Hungary. Together, we ensure high-quality products with low user risk for our end-users to provide them with the best possible experience.

 
“Even with our work being very project-based, we have a strong team spirit with check-ins and social activities. Working with risk assessment, we deal with subjective experiences, so it’s important that we meet up to align our input, support each other and share learnings,” explains Henrik.
 

Influence the quality of our medical devices
When a medical device is developed, there are numerous rules and regulations that every medical device company has to adhere to. In this position you will play a key part in ensuring compliance by maintaining a sound risk profile and supporting our Design Control processes. It is always about ensuring that the benefit of the product by far outweighs the risk of using it. That is where you make a difference. 

 
Working project-based, you will be involved in 2 – 4 projects at the time. The projects are focused on the redesign/maintenance of the product, and you will own the design control process in each project as a member of each project core team, ensuring that we follow our design control model. 

 
Specifically, you will:
•    Carry out hazard analyses and risk assessment
•    Give input on how to mitigate risk in the redesign process
•    Build documentation for each product
•    Carry out risk/benefit analyses
•    Collaborate with colleagues across R&D, Product Support, Regulatory Affairs, Clinical and Medical affairs as well as commercial colleagues
  

“We evaluate each product with a clear focus on safety and quality. At the same time, we aim to balance high standards with the ability to timely deliver solutions that are ready to truly make a difference to our end-user”, says Henrik.

 Do you have risk assessment experience?
In this role, a structured approach and a listening ear will get you far, as you will need to gain important input from your colleagues and our systems to make your assessments. So, while you are a specialist who enjoys working in-depth, you also have to like interaction with colleagues and networking across the organisation.

 
Finally, we imagine that you:
•    Have a scientific background
•    Have some years of experience with product risk assessment
•    Enjoy working with analysis and have the curiosity to understand the technicalities of a product and the users of it
•    Experience from the medical device sector is an advantage but learnings from other sectors could also be relevant
•    Are fluent in English
 

Interested? 
If you would like to know more about the position, please call Henrik Edvardsen, Head of LCM CC & BC at DKHED@coloplast.com. We will take candidates into the recruitment process after the summer break, but do not hesitate to apply as we’ll be screening continuously. This position will remain open until a suitable candidate is found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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