Job Description

Do you want to join the creation and development of the new manufacturing for our Continence Care segment within Coloplast?

Be a service partner for/and support the supply of our customers, from a quality function, to ensure the products our users’ needs are sterile?

Then look at this position: Release Specialist

Here you will play a key role in the quality of the products produced as a partner in release process of products and troubleshooting for ongoing sterilization of our products. You will play a pivotal role in ensuring the success of our roll-out plan and be the gate keeper for sending products to market and to our users, from our new site as the release of sterile goods is the final stamp of approval.

Your challenge:

• Support and promote the quality culture for the whole site
• Lead, execute and document quality control activities for Sterile Release
• Be the approver of documentation related to work area
• Train, instruct and guide the organization on site within Sterile Release
• Support production – Partner towards production for changes, troubleshooting, deviations and improvement activities
• Own non-conformities for sterilization related deviations
• Participate in projects in relation to launch activities, and potential problem solving of technical process problems in relation to Sterilization
• Be the 1 point of contact towards Sterilization Site

Your Qualifications:

• Academic background:A relevant academic background (B.Sc. or higher).
• Experience:
• Minimum 2 years as an Engineer / Specialist within Sterilization or Quality or similar within a production environment
• Solid understanding within the field of Quality in relation to production i.e. GDP, Certificates, and GMP etc. (Quality Assurance experience is a plus)
• Knowledge of production documentation from quality point of view, DMR, QC, CoC, COA, etc.
• Project knowledge and experience
• Production knowledge – Value chain understanding
• Business understanding:Holistic understanding of End-To-End production
• Language Proficiency:Fluent in spoken and written English (other languages are a plus).

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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