Senior Medical Device and Combination Product Expert

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Hillerød

Are you looking for an exciting opportunity as Quality responsible for Medical Devices and Combination Products? Are you enthusiastic about setting quality standards for New Product introduction and ready to play a key role in launching innovative, life-changing products in new countries? Then apply today and join us in Device Manufacturing Development (DMD), Projects, and Product Control Development. The position As Senior Device Engineer, you collaborate with a broad stakeholder landscape and in different projects to develop Control strategies within Manufacturing, Release and Submission of medical devices and Combination product testing. You are involved every time a new Site or a new Contract Manufacturing Organisation (CMO) will be implemented globally. Most of the CMO’s are in Europe and USA. You will be part of a highly engaged and dedicated professional team, and your responsibility will be to own, develop, and optimize Device Quality Frame Specifications (QFS) and associated documents for example submission. These specifications determine if the Drug Device Combination products have the required quality to be released for next process in the value chain and are vital to ensure that Novo Nordisk delivers a quality product to patients all over the world. The purpose of a QFS is to translate related design inputs, design outputs and safety risk management outputs into a specification to ensure quality and safety requirements needed to release an injectable finished product. Some of your key activities include:
  • Working with regulations, risk documentation, and quality control to set up requirements and parameters for testing during production (In-Process Control) and in Quality Control (QC)
  • Becoming an expert of the submission process for new countries or new product introduction
  • Being part of cross functional project groups responsible for implementation and improving quality level of new combination products and acquisition products
  • Providing global production/QC support and take part in driving improvement projects on own internal processes
    • There will be opportunities for travel activities in small scale (1 time a year). Qualifications To be successful in this role, we imagine you:
  • Have previous experience within quality assurance or regulatory affairs and have worked with suppliers in a global environment
  • Hold a Master’s degree within relevant Engineering disciplines, biotechnology pharmacy, veterinarian, or equivalent
  • Demonstrate fluency in both written and spoken English
    • It would be considered a strong advantage if you possess knowledge of ISO13485, GMP, validation, and Lean. On a personal level, you make a difference and through your commitment and perseverance, you complete your tasks in close cooperation with your colleagues. You are collaborative and enjoy sharing knowledge and experiences with stakeholders. You’re independent and not afraid to take the initiative and make decisions. We also welcome applicants from other branches, as long as you share our passion for quality, GMP, and problem solving and are keen to acquire professional competencies to become what we describe as an “ideal candidate”. About the department You will be part of DMD, Product Control & Global Support, where we support device development from the early R&D development stages into production for clinical trials and finally into production to market. We are a team with Specialists and Experts that are both Danish and international, coming from various educational, as well as cultural backgrounds. We complement one another’s knowledge and skills, always seeking to help and support when someone needs it. At work we try to keep a light and informal tone, so if you can bring a dose of healthy sense of humour along, then you will fit right into the team. Working at [xxxxx] We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at [xxxxx], life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Charlotte Hunding, Senior Manager, Projects and Product Control Development at +[xxxxx]. Deadline 10 April 2023. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your resume. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 26.3.2024, men kan have været deaktiveret og genaktiveret igen.

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    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 16.04.2024
    • Øvrige
    • Hillerød
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