Specialist with equipment qualification, validation, and calibration focus

Do you have knowledge of equipment qualification, validation and calibration?  And would you like to help ensure that our products meet the regulatory requirements, and are able to fulfill user’s needs? 
  
Then grab this opportunity to join one of the best-performing medical device companies in the world and help make a difference for people with intimate health care needs across the globe. 
  
“As specialist in validation of test equipment, you will be instrumental in ensuring that the test equipment and software used for various test of medical devices are qualified and the right equipment validation strategy is implemented” says Lou Rasmussen, Manager of EHS & Metrology. 
 
A growing team of specialists 
You will become part of an established EHS & Metrology team, which is an integral part of the Test & Characterization organization within R&D, where we lead the design, documentation, and execution of our test strategies.

The team is taking the lead in the qualification, validation, and calibration of all our test equipment used for developing tests and product documentation in R&D and consists of 12 persons, this position is a further expansion of the team. We encourage diversified candidates to apply despite if you are newly educated engineer or current senior specialist.
 
 “The EHS & Metrology team owns the equipment qualification, validation and calibration process, and we are constantly working to improve it - giving you a lot of influence in your daily work. In addition, we are a very supportive team, and you will have plenty of opportunity to collaborate with various peers.” Lou Rasmussen explains. 
  
From early-stage concepts to final product  
 Stepping into this role, you become our subject matter expert and a technical lead on equipment qualification and validation together with our test method specialists. Thus, you can look forward to planning-out equipment qualification activities and documentation to ensure that the output from our equipment and tests meets our design requirements in our development projects.

You will be working closely with our laboratories and various stakeholders across R&D throughout the product design and development process.
  
More specifically, your key tasks include: 

 •    Driving equipment qualification and validation activities across projects in accordance with internal processes and regulatory standards 
•    Working with development scientists and test engineers to determine the appropriate qualification, validation level and evidence required to meet the functional requirements. 
•    Setting the qualification and validation strategy and execution plan 
•    Acting as subject matter expert for equipment qualification and validation 
•    Utilizing your previous experience with medical device product documentation 
 
It is vital that you thrive in a project-based environment. You know how to navigate a diverse stakeholder landscape and coordinate and facilitate tasks that span both quality and regulatory requirements as well as multi-disciplinary disciplines. 

Moreover you: 
•    Hold a technical degree e.g. engineering within medico, mechanics, physics, chemistry or a similar discipline  
•    Have experience with validation and equipment qualification (IQ/OQ/PQ) 
•    If possible, bring 2+ years of experience working with ISO 13485 and FDA  
•    Excellent at reading and writing technical documentation. 
•    Have experience of test methods for chemical, mechanical and/or material requirements 
•    Speak and write technical English, Danish optional
  
Interested?  
If you would like to know more about the of this position, please contact Manager of EHS & Metrology, Research & Development, Lou Rasmussen at dklou@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.

Visit us on Coloplast.com.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

58296
#LI-CO