Process Risk Specialist for Innovation Quality Assurance department

Imagine if all the new Coloplast production processes started with… you! It is no exaggeration. As our process risk specialist, all future products and processes will start with you and your colleagues, located here at our manufacturing development site .

Do you want to play a key role in ensuring that new products and processes meet the highest quality and compliance standards before they reach production? Are you passionate about building manufacturing systems and processes based on production risk management and working closely with other skilled specialists - We offer you an interesting role – a hybrid between R&D and global Operations where you will gain full responsibility for process risk management building our new manufacturing systems.

“This role offers a unique opportunity to work at the intersection of product development, process development, and operations. You will help ensure that our products and processes are built on a solid foundation of quality and compliance from the very start” says Nicole Damm Appelby, Head of Pilot QA.

Help shape the quality of future products from the very beginning
You will join a team of quality and process risk professionals supporting both development projects and ongoing process improvements. We work closely with project teams, engineers, process specialists, laboratory experts, and manufacturing stakeholders to establish and maintain high-quality standards throughout the product lifecycle.

The environment is dynamic and collaborative, providing opportunities to influence projects from early development. We take ownership of process risk management and are proud to serve as quality gatekeepers throughout the product lifecycle. In this role, you will help ensure that risks are proactively managed and that the right mitigations are implemented to support compliant, robust, and scalable manufacturing systems. By balancing innovation, quality, and operational needs, you will play a key role in enabling successful product and process implementation while safeguarding the appropriate level of quality.

Drive process risk activities across projects
As specialist, you will be a key quality partner in cross-functional projects. You will facilitate risk management activities. Define validation strategies and ensure that validation activities are executed in compliance with regulatory and internal quality requirements.

Your responsibilities will include:

•    Responsible for process risk assessments and ensuring appropriate risk mitigation measures are implemented throughout the full manufacturing system
•    Defining and maintaining validation strategies for innovation projects
•    Reviewing and approving validation documentation, protocols, and reports
•    Supporting change control activities and ensuring validated states are maintained
•    Providing process expertise to project teams and stakeholders across R&D and Operations
•    Contributing to audits and inspections
•    Driving continuous improvement of processes, templates, and quality systems
•    Supporting the development and maintenance of quality procedures and internal standards

Success in this role requires a strong ability to engage with stakeholders from different professional backgrounds. You thrive in a collaborative environment and are comfortable challenging assumptions while maintaining a practical and solution-oriented mindset. 

You understand how quality requirements support business objectives and can balance compliance with project needs.

You will navigate this with 9 other close colleagues who are very passionate about quality and safety and have a broad range of experience.

As accountable for process risk management
You are a collaborative team player with excellent communication skills and a natural ability to build trust across functions. You thrive in a dynamic environment, can navigate complex stakeholder landscapes, and consistently maintain a holistic perspective on quality, compliance, and risk.

Finally, we imagine that you:

•    Have a master’s within the STEM field
•    Have a background as e.g. project lead or quality related specialist roles
•    Have operational experience
•    Previously track record of working with process risk management
•    Have MedTech experience
•    Are fluent in English and preferably also Danish

Interested?  
If you would like to know more about the position, please reach out to Head of Pilot QA, Nicole Damm Appelby on Se e-mailadresse på careers.coloplast.com. 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.

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