Location:
Humlebæk, DK
Job Family: Research & Development
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Country/Region: Denmark
Do you have knowledge of Equipment Qualification and Validation for Design Verification of Medical Devices? And would you like to help ensure that our products not only meet the requirements but are also premium quality and fulfilling our customer 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 one of our experts on validation of test equipment that we use for Design Verification, you’ll be instrumental in ensuring that the test equipment incl. Software used for DV test on our products are tested in a sound manner, that the right validation strategy is implemented, and that the design is verified in a clearly traceable manner.” - Majk Kruszewski, Head of Test Engineering.
A newly established team of specialists
Joining R&D at our HQ in Humlebæk, Denmark, you become part of a newly established and still growing team of experts within our Test & Characterisation department.
We are in charge of leading the design and documentation of our testing strategies and responsible for ensuring that those test strategies and methods are implemented at Coloplast sites around the world.
“It’s a very supportive team, so you’ll have plenty of opportunity to collaborate with your peers. What’s more, we own the Design Verification and Equipment Qualification process and are constantly working to improve it, giving you a lot of influence in your daily work,” Mikael explains.
From early-stage concepts to final product
Stepping into this hands-on role, you become one of our subject matter experts and a technical lead on equipment qualification and validation in projects. Thus, you can look forward to planning out equipment validation activities, designing corresponding tests, analysing data and ensuring that the output from our equipment and tests meets our design requirements.
Doing so, you will be working closely with various stakeholders throughout the product design and development process as well as with our test labs.
More specifically, your key tasks include:
Driving equipment qualification and validation activities for design verification across products in accordance with internal processes and regulatory standards
Working with development scientists and engineers to determine the appropriate methods, validation level and evidence required to meet the design requirements
Setting the validation strategy and execution plan
Acting as gatekeeper and subject matter expert for equipment qualification and validation
Utilizing your previous experience with medical device product development
Though you will not be managing projects yourself, it is vital that you thrive in a project-based environment. You know how to navigate a diverse stakeholder landscape, and how to coordinate and facilitate tasks that span quality and regulatory requirements as well as multi-disciplinary technical teams.
Moreover, you:
Hold a degree in engineering, e.g. within mechanics, physics, chemistry, or a similar discipline
Have solid experience with validation and equipment qualification (IQ/OQ/PQ)
Bring 2+ years of experience working with ISO 13485 and FDA QSR
Excel at reading and writing technical documentation
Have knowledge of test methods for mechanical and material requirements
Speak and write technical English
Interested?
If you would like to know more about the position, please contact Head of Test Engineering Mikael Kruszewski at dkmkru@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 14.000 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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