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Senior Test Method Specialist

Location: 

Espergærde, DK

Job Family:  Quality Assurance
Country/Region:  Denmark
Senior Test Method Specialist 

This is your chance to put your solid technical know-how on test methods and equipment into play – and challenge your skills as you work within our many test methods 

 

Join us and become part of a specialist team where you will play a crucial role in taking our test methods to the next level with a focus on simplicity and transparency in our ways of working.

 
“You’ll be based at our pilot plant where we innovate and mature production processes for new Coloplast products and equipment for volume production. Focusing on our QA laboratory and our supply value stream, your work will ultimately help ensure the best products for people with intimate health care issues across the globe,” explains Rikke Christensen, Head of Pilot QA, Global Quality & Regulatory Affairs.


Be part of a highly engaged team of Specialists

At our pilot plant in Mørdrup, Denmark, you will be part of our Global Quality Regulatory Affairs organisation. Working alongside 15 dedicated colleagues in our Pilot QA team, you will join the 5 QA specialists operating in a dynamic and professionally challenging work environment and supporting our supply value stream and innovation value stream. Moreover, you will be collaborating closely with another test method specialist covering the Innovation value stream at the plant – and in general, you will collaborate with colleagues across the organisation as you do what you do best.


Responsible for test methods and test equipment 
You will be responsible for the broad array of test methods and test equipment in our QA laboratory and our supply value stream at the pilot plant – both in connection to new product innovation as well as volume production of existing Coloplast products. Thus, you will be our test method superuser with the expert knowledge needed to train your colleagues and troubleshoot when methods or equipment fail. 

Supporting and representing the pilot plant in all activities from test method development, qualification of test equipment to the maintenance of these, you will: 

 

  • Maintain a high test method understanding in the pilot plant through training of specialists, technicians, operators and others in test methods and use of test equipment  
  • Issue and maintain OPLs related to specific test method and equipment
  • Share knowledge about test methods and test principles through close collaboration with process specialists and test method specialist in R&D and Global Quality giving input to development of new test methods
  • Ensure that test equipment is qualified and calibrated according to used test methods as well as maintained and able to perform as intended 
  • Evaluate test results and troubleshoot when needed using root cause investigation
  • Issue test equipment qualification documentation as well as protocol/reports
  • Perform and participate in transfer activities related to transfer of test methods and equipment to our international manufacturing sites

 

Push your knowledge to new limits
As we have a wide array of test methods, we are looking for a colleague who is not afraid to stretch and expand their technical know-how – both when it comes to working on test methods but also when issues arise. You tackle challenges by taking an organised approach to gather all the details. Moreover, you need to have excellent communication skills as you will be working with multiple colleagues – from technical specialists to operators on the production floor. We also imagine that you:

 

  • Hold a master’s degree within science (e.g., mechanics/physical, chemistry, technical, pharmacy or similar) and have solid experience with test methods
  • Have knowledge of ISO 9001 and, preferably, also ISO 13485 and GMP
  • Take an analytical approach to the assessment of corrective and preventive action and have an advanced level of problem-solving skills
  • Have great IT skills and are eager to learn how to work with our tools such as Trackwise/E1, Veeva, 6Sigma and SAS JUMP (at least Green Belt training) as well as with documentation/traceability of raw data 
  • Are fluent in English

 

Interested? 
If you would like to know more about the position, please call Head of Pilot QA, Global Quality & Regulatory Affairs, Rikke Christensen on +45 4911 1633. 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 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. Follow us on LinkedIn. Like us on Facebook.

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