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QA Specialist (Maternity Cover 12 months)

Location: 

Espergærde, DK

Job Family:  Quality Assurance
Country/Region:  Denmark
QA Specialist (Maternity Cover 12 months) 

QA specialist, Maternity Cover (12 months) for Pilot Plant, Mørdrup 

Would you like to provide quality assurance to help one of the best-performing medical device companies in the world to ensure product quality globally?

If so, join a highly engaged team operating in a dynamic and professionally challenging working environment, where you will have the opportunity to grow and expand these skills even further collaborating with a large network of stakeholders and ensuring that our QA deliveries meets applicable requirements.

Operation and process alignment
As part of the Quality department, you will be based in our Pilot Plant located in Mørdrup, 40 kilometers north of Copenhagen. Working alongside 15 dedicated colleagues in Quality, you will be one of the 5 QA specialists involved in our Supply value stream and Innovation value stream at Pilot Plant.

Your role involves a high degree of cross-organizational collaboration. In addition to working closely with your colleagues in the operation teams, you will have a close link to R&D functions, as well as the Global Quality& Regulatory Affairs organization in Headquarter/Humlebæk. 

You will collaborate with the International Manufacturing Sites located in Hungary, China, and Costa Rica, providing QA support to our colleagues ensuring that quality is in place. 

Ensure compliance with Coloplast Quality Management system
Your main task is to support operations and ensure a compliant QA set-up is used for production. You will be involved in projects and contribute with quality knowledge in these.  You deliver high quality at a high pace. Specifically, you:

•    create and maintain Quality set-up (Quality- and Control Plans, DMR index, quality records etc.).
•    deliver inputs from a quality and production perspective in the product development projects.
•    Handle change requests to continuously improve quality of our processes and products.
•    Handle, creation, disposition, approval, and closure of non-conformity reports.
•    Participate in internal/external audits.

Strong stakeholder management skills and drive
In this role, excellent communication and stakeholder management skills are vital. On a personal level, you are highly driven and know how to take ownership of your tasks and push an idea through. 
Your sense of humor and ability to listen makes you a good team player, and you enjoy collaborating and sharing knowledge with your colleagues. Project work and collaboration in an international organization suits you well because you appreciate the dynamics of a fast-paced and changeable work environment.

•    You hold a BSc or MSc in pharmacy, engineering, or a related field.
•    Preferably you have quality experience within the medical device or pharmaceutical industry, including ISO9001/13485 & GMP.
•    You take an analytical approach to the assessments needed in your work.

Need more information
For more information, please contact Head of Pilot QA, Rikke Christensen by mail: dkrla@coloplast.com or phone: +45 4911 1633.

Deadline
Please send your motivated application with CV in English via www.coloplast.com/jobs, no later than 1st of July 2021. 
 

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 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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