Process Owner, Design Control & Risk Management

Humlebæk, DK

Job Family: Quality Assurance

Country/Region: Denmark

Would you like to take up a global 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?
Would you like to immerse yourself in risk and quality assessment working closely together with stakeholders across the company at all sites?

Then come join us! We are currently looking for a process owner to take responsibility for Risk Management and Design Control processes.

“Being global process owner of Risk Management and Design Control, you get to combine your specialist knowledge within Risk Management and Design Control across the company. Work never gets dull. You collaborate with many stakeholders ensuring we are always up to date with current regulations and guidelines” 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, risk management and design control. You will join the Design Control team of 5 specialists. Together, we ensure high-quality products with low user risk for our end-users to provide them with the best possible experience.

The team is working project based by focusing on the redesign/improvement of a product, and your colleagues in the team 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. You expect to guide your colleagues and spare in projects, when needed.

“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 risk management and design control processes are continuously maintained and 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.

Specifically, you will:

• Ensuring compliance with valid standards and legal requirements for the assigned global quality processes with focus on ISO14971
• Continuously support and development the assigned global quality processes, in accordance with customer needs and with one company mind-set
• Have decision power for own processes, regarding deploying process implementation, as agreed with Global QA/RA management
• Ensure proper training material and provide training across functions
• Support audits and inspections with specialist knowledge
• 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 to the industry will get you far, as you will need to gain important input from external guidelines and regulations ensuring implementation in global and local procedures. So, you will have to like the interaction with colleagues and networking across the company.

Finally, we imagine that you:

• Have a scientific background
• Have experience from the medical device or pharmaceutical industry within Quality Management systems, especially in design processes and risk management according to ISO14971
• Enjoy working with analysis and have the curiosity to understand the technicalities of a product
• Bring a strong knowledge of relevant external requirements e.g. FDA, MDD/MDR and ISO
• Have experience with audits and inspections
• Experience with stakeholder management, process optimisation, cross cultural and organisational communication
• 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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