Stability Specialist

About the Department

The department consists of 6 colleagues covering 3 main functions: Packaging Specialist, Quality Specialist and Design Control Specialist.
The team’s primary responsibility is to create and maintain design documentation for existing products and to verify product functionality throughout raw material changes.

Your Role

As a Stability Specialist, you will be responsible for creating and maintaining stability and transportation studies, as well as supporting SVS and material change projects from a stability perspective.

Key Responsibilities

• Support the maintenance of the existing product portfolio, SVS projects and material change initiatives

• Handle non-conformances (infrequent, approximately one case every six months)

• Support shelf-life extension activities for raw materials, intermediates and finished goods

• Create and update stability and transportation documentation related to product changes

• Set up stability studies, report on ongoing studies and keep the overall stability overview up to date

• Participate in transportation studies and report on product performance within the documentation

• Build and maintain strong collaboration with the Global Quality stability team in Denmark

• Ensure proper documentation and follow-up of change requests

Your Qualifications and Skills

• Fluent in spoken and written English

• Scientific academic background (e.g. MSc in Engineering, Quality or similar)

• Strong background in quality and stability

• Relevant experience in stability documentation, medical devices and/or pharmaceuticals

• Analytical mindset with structured problem-solving skills and a strong methodological approach

• Knowledge of applicable regulatory and quality standards within the Medical Device industry

• Willingness to travel (approximately 10 travel days per year)

• Strong IT skills, especially Microsoft Office, Excel and PowerPoint

• Team player with a collaborative mindset

• Experience working in an international, cross-functional and cross-cultural environment

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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