Quality Supporter

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Hillerød

Do you want to join a project organisation that brings innovative medical devices from development to launch readiness? Would you like to use your quality expertise to play an active role in and outside our department? Does your mindset include a persistent focus on quality in everything you do, and do you thrive in an organisation in constant development? Then apply today as you might be the Quality Supporter we are looking for to join our Pilot Operations department! The position As a Quality Supporter, you will be responsible for adapting the quality and compliance level in an everchanging environment where assignments and priorities often change. You will support the entire unit but you will mainly work closely together with our Process Responsible, Engineers, skilled Technicians, and Operators. Your main focus will include:
  • Ensuring compliance in all we do including daily operations, projects, and continuous improvements
  • Maintaining and improving work instructions, and analysing quality data
  • Balancing the different requirements needed, for example for explorative tests and production to clinical studies
  • Handling quality activities and deviations across the team and the department
  • Supporting verification and validation process equipment and components
    • Qualifications On a personal level, you are known for dedicating yourself to work proactively to solve the tasks at hand. You face challenges with a positive and open mindset to find the best solution in collaboration with our stakeholders. Furthermore, you can make independent decisions and navigate in a complex regulatory environment. Last but not least, you possess excellent communication and interpersonal skills and enjoy interacting with many different stakeholders. To be considered for this position, we expect you:
  • Hold at least a bachelor’s degree in engineering or any other relevant field
  • Demonstrate expertise with documentation of quality and compliance in relation to Good Manufacturing Practice (GMP)
  • Are fluent in Danish (written and spoken) and English (both written and spoken)
  • It would be considered a plus if you are familiar with ISO standards used within the pharmaceutical industry, LEAN, and digital solutions ChatGPT, Copilot etc.
    • About the department The unit Finished Product Manufacturing Science & Technology (FPMSAT) is a project organisation comprising more than 700 engaged employees who all contribute to becoming the best manufacturing development partner of medical devices. Our dedication is to build superior quality into robust device products suitable for high-volume production. FPMSAT Pilot Operations is a flexible development and test facility within FPMSAT that supports device development from early R&D development stages into stable production to market. You will be part of the Moulding and Quality Support team consisting of 10 engaged and dedicated colleagues, and you will be responsible for quality support in our team as well as across Pilot Operations. In the Moulding Test Centre, our focus is to perform explorative tests and optimize and validate injection moulding processes. We service our stakeholders by testing machines, moulds, mould concepts, materials, etc. ensuring reproducibility and the optimum of technical, economic, and environmentally sustainable solutions. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
    For further information, please contact Claus Munk Mikkelsen at [xxxxx]
    Deadline 18 March 2025. 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 or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 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.


    Information og data

    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 5.3.2025, men kan have været deaktiveret og genaktiveret igen.

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    • Hillerød
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