Design Control Specialist - ensure safe, high-quality products

Humlebæk, DK

Job Family: Quality Assurance

Country/Region: Denmark

Would you like a job in a project office – with time and room to immerse yourself in risk and quality assessment alongside specialists? And would you like to take up a core function in 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 Design Control Specialist.

“Taking ownership of the 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 Malene Schack Jørgensen, Head of Stability, packaging and Design Control.

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 stability, packaging, transportation and design control. You will join the Design Control team of 5 specialists and a process owner. Together, we ensure high-quality products with low user risk for our end-users to provide them with the best possible experience.

“Because our work is project-based, we make an effort to meet regularly as a team. Working with risk assessment, we deal with subjective experiences, so it’s important that we have meetings to align our input and support each other,” explains Malene

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 major part in that, ensuring a suitable risk profile and that the design control process is followed. 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 attached to 2-4 projects at a time. The projects are focused on the redesign/improvement of a 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 Marketing

”Each product is subject to evaluation. We’re not perfectionists, but very pragmatic when it comes to assessing when a product is good enough to truly make a difference to the end-user,” says Malene.

Got 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 make your assessments. So, while you are a specialist who enjoys working in-depth, you also have to like the interaction with colleagues and networking across the organisation.

Finally, we imagine that you:

• Might have a scientific background
• Have some years of experience with risk assessment
• Enjoy working with analysis and have the curiosity to understand the technicalities of a product
• Might have experience from the medical device sector
• Are fluent in English

Interested?
If you would like to know more about the position, please call Malene Schack Jørgensen, Head of Stability, packaging and Design Control at +45 4911 3064. 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.

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.

Visit us on Coloplast.com.

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