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Test Method Specialist

Coloplast
Region Hovedstaden
for 1 dag siden
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Location:
Espergærde, DK

Job Family: Quality Assurance
Country/Region: Denmark

Do you want to work on test method improvement in an exciting Pilot Plant? Can you envision yourself in a team with diverse stakeholders and tasks, where you can influence how we approach things?

“Our test process setup directly impacts global production, which then serves people needing intimate health care products. For me, that makes this job both meaningful and exciting!” - Camilla Soltau, Team Manager, QA Lifecycle Laboratory

We believe in high quality and close collaboration
At our Pilot Plant in Espergærde, you will join our QA laboratory team, which is responsible for supporting our QA laboratory and established production in our pilot plant by delivering timely, qualified lab results and ensuring regulatory compliance and documentation.

You can look forward to joining a tight-knit team that knows great results come from shared knowledge and flexibility when things change. As a mix of laboratory technicians and a senior test method specialist, we continually learn from the diverse skills that each of us brings to the table.

When priorities shift – which is not uncommon – we navigate together as one team. Because it is our firm belief that the best results come from collaboration.

Support the optimisation and maintenance of test methods and test equipment
Collaborating closely with our senior test method specialist, you will work on test methods for QA/QC within our Global Quality organisation and mature manufacturing. You will be responsible for test methods and related test equipment, primarily related to our QA laboratory and production.

Your responsibilities will include the optimization and maintenance of our equipment and methods used in the QA laboratory, to ensure its operational integrity and support best practices.

This also includes training laboratory technicians, setting calibration parameters and setting up our processes for LIMS implementation.

As a test method specialist, you will develop in-depth technical expertise within specific methods and related equipment. More specifically, you will:

Manage qualification of test equipment – e.g. coordinating replacement of critical parts and relocation or capacity expansion
Evaluate test results and troubleshoot when needed using root cause investigation
Participate in transfer activities related to the transfer of test methods and equipment to our international manufacturing sites
Provide support to different functions at the Pilot Plant as well as international manufacturing sites, regarding test methods and test equipment
Collaborate, align with and support our Global Test Method team

Grounded in statistics, fluent in technology and clear in conversation
You are a collaborative individual who looks forward to contributing to our team with your strong problem-solving mindset. Your structured and systematic approach, combined with the ability to communicate effectively with almost anyone, enables you to participate in interdisciplinary projects with ease.

We are also looking for you to bring:
A few years of experience, preferably with mechanical and physical/chemical test methods (but training will be part of your onboarding)
An MSc/MS, giving you a strong foundation in statistics
A proven ability to read, write and understand technical documents
Knowledge of ISO 9001, and preferably also ISO 13485 and GMP
Excellent communication skills in English, both technically and conversationally
IT skills, including proficiency in Microsoft Office and experience with quality and data management tools such as Veeva, 6Sigma, and SAS JUMP, as well as expertise in documenting and ensuring the traceability of raw data

Interested?
If you would like to know more about the position, please contact Team Manager Camilla Soltau at [email protected]. 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.

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