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Test Method Specialist (Maternity Cover 15 months)

Location: 

Humlebæk, DK

Job Family:  Research & Development
Country/Region:  Denmark
Test Method Specialist (Maternity Cover 15 months) 

Maternity Cover (15 months) – test method specialist for Life Cycle Laboratory which is a part of our Research and Development (R&D) Chronic Care and Wound Care
 

Would you like to provide documentation to help one of the best-performing medical device companies in the world to ensure product safety for Chronic Care and Wound Care globally?
 
Pursue a career within one of the best-performing medical device companies in the world and be part of the entire development and documentation process – from initial concept tests to final products. Feel the pride and see your efforts help make a difference to people with intimate health care needs.
 
About the Team
The Life Cycle Laboratory Team is an integrated team within R&D Adhesives in Coloplast headquarters in Humlebæk, Denmark. The team consist of 9 dedicated people to support our Wound and Chronic Care products range, where your roll will be as a test method and equipment specialist responsible for proper documentation according to MDR and MDSAP of our test methods and laboratory equipment’s used for our existing products range within the Wound and Chronic Care business areas. 


“Before new and existing products are brought to the market, we ensure the right documentation for our design verification and test methods. Essentially, your work will ensure that our customers can put their trust in our products. In that way, you’ll make a true difference to people with intimate health care needs” explains Head of Life Cycle Laboratory Lou V. Rasmussen.

 

Ensure the quality of our test methods
As a test method and equipment specialist in the Life Cycle Laboratory, you are responsible for ensuring documentation at the right level concerning the design and validation of our test methods used for design verification, stability studies and transportation studies. This means that you participate in analyzing raw data and creating documentation like validation reports and related procedures and instructions. 
 
Participating in the constant upgrade of test method principles and structures in R&D Coloplast, your key responsibilities include:
 
•    Creating and approving validation documentation for design verification and related test methods and equipment for medical devices (Class I-III).
•    Actively participate in our MDR Wound Care projects and the ongoing maintenance of test methods implemented in our Laboratory.
•    Participate in troubleshooting of laboratory equipment as well as in the design of new and existing test equipment/test methods.
•    Facilitate training of colleagues in test methods, lab equipment, instructions, and procedures. 
 
Scientific background and a flair for test methods
As you will work as specialist in the test method documentation’s part and thereby will collaborate closely with other parts of our R&D and especially with our Quality Support department. You must be able to work well with colleagues, give your feedback to ensure we create documentation on the right level and meets our deadlines. Also, you will be responsible for the qualification and validation documentation of our different laboratory equipment’s in the Life Cycle Laboratory, so structure is crucial. 
 
We imagine that you:
 
•    Hold a master’s degree within science (e.g., mechanics/physical, chemistry, technical, pharmacy or similar) 
•    Have experience with design control, validation and/or test method documentation from a regulated industry (preferably within the medical device industry) or from the University
•    Have experience with specific equipment qualification and test method validation
•    Have an analytical approach to your work including having an advanced level of problem-solving skills and have knowledge of statistics and statistical software (e.g. SAS JMP or Six Sigma)
•    Have great IT skills and are eager to learn how to work with our tools such as Trackwise, Veeva and SAS JMP 
•    Have knowledge of ISO 9001 and, preferably, also ISO 13485 and GMP
•    Have excellent English communication skills, both verbally and in writing
•    Finally thrive to ensure high quality documentation related to test method validation documentation and equipment qualification.

 

As a person you are dedicated, open-minded and used to work in teams. You are structured and proactive, ideally combined with a positive mindset and a good sense of humour.

 

Interested in this position as test method specialist - maternity cover (15 month)?
At Coloplast, we make sure that you can be you. That is why we encourage applications from suitably qualified and eligible candidates regardless of sex, race, ethnicity, disability, age, sexual orientation, gender reassignment, religion or belief or marital status.
 
If you would like to know more about the position, please call Head of Life Cycle Laboratory Lou V. Rasmussen +45 4911 2612. 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.

 

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