Design Control Specialist (Maternity Cover)
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Humlebæk
Are you motivated working with design control and risk management in a high performing quality environment where you participate in securing the right documentation for users with intimate healthcare needs?
Then join Global Quality and Regulatory Affairs in this maternity cover, to become part of one of the best performing MedTech companies in the world.
About the department
In Humlebæk, Denmark, you become part of Post Market Surveillance & Quality Processes, a department within Global Quality & Regulatory Affairs consisting of 10 highly skilled specialists. We are an engaged team of 3 Design Control specialists, 4 Vigilance specialists, and 3 Process owners. The DC specialists in our team take pride in creating high quality documentation through a structured and involving process, where we together with other specialists to find pragmatic solutions to document Coloplast products according to current regulations.
The job
As Design Control Specialist you:
This is a 1-year temporary position that will end January 1st 2021 with the possibility of exstension.
Your qualifications
You have a degree in engineering, pharmacy, life science or similar. Preferably, you have experience with design control, product risk management, usability engineering or quality assurance in the medical device industry. Furthermore, you have:
On a personal note you are a true team player with a positive and flexible mindset, who understands how to reach joint goals. You have a proactive mind-set and a constructive attitude to drive results combined with the ability to plan, execute and meet deadlines. You enjoy working with multiple tasks at the same time and are analytical and capable of digesting complex data without losing the overall picture.
Need more information?
For further information please contact HO PMS & QP, Lotte Dock Steenstrup, at +45 4911 3254.
Deadline
Please send your application no later than February 10th, 2020. We will take candidates into the recruitment process continuously, so do not hesitate to apply.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 12,000 people and with products available in more than 140 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. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
Then join Global Quality and Regulatory Affairs in this maternity cover, to become part of one of the best performing MedTech companies in the world.
About the department
In Humlebæk, Denmark, you become part of Post Market Surveillance & Quality Processes, a department within Global Quality & Regulatory Affairs consisting of 10 highly skilled specialists. We are an engaged team of 3 Design Control specialists, 4 Vigilance specialists, and 3 Process owners. The DC specialists in our team take pride in creating high quality documentation through a structured and involving process, where we together with other specialists to find pragmatic solutions to document Coloplast products according to current regulations.
The job
As Design Control Specialist you:
- Drive design control activities in projects to provide documentation support for the regulatory files
- Are responsible for the product risk management process and documentation
- Contribute to the progress of design control in projects for example through facilitating design reviews. This includes planning, reporting and documentation of the work in close cooperation with a variety of stakeholders
- Implement requirements originating from standards.
This is a 1-year temporary position that will end January 1st 2021 with the possibility of exstension.
Your qualifications
You have a degree in engineering, pharmacy, life science or similar. Preferably, you have experience with design control, product risk management, usability engineering or quality assurance in the medical device industry. Furthermore, you have:
- Knowledge of regulations, standards and guidelines within the medical device area e.g. MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30
- Experience with driving and documenting design control activities such as the creation of design input and outputs, design verification and facilitating design reviews
- Experience with facilitating product risk management activities and creating the risk management file
- Experience with usability engineering
- A good understanding of complex technical issues
- Strong communication skills and are fluent in English – both verbal and written.
On a personal note you are a true team player with a positive and flexible mindset, who understands how to reach joint goals. You have a proactive mind-set and a constructive attitude to drive results combined with the ability to plan, execute and meet deadlines. You enjoy working with multiple tasks at the same time and are analytical and capable of digesting complex data without losing the overall picture.
Need more information?
For further information please contact HO PMS & QP, Lotte Dock Steenstrup, at +45 4911 3254.
Deadline
Please send your application no later than February 10th, 2020. We will take candidates into the recruitment process continuously, so do not hesitate to apply.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 12,000 people and with products available in more than 140 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. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Humlebæk.
Jobbet er oprettet på vores service den 30.1.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- Humlebæk
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Statistik over udbudte jobs som produktspecialister i Humlebæk
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Statistik over udbudte produktspecialister i Humlebæk over tid
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