Senior QA in Assembly and IT

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Hillerød

Do you want to use your strong quality mindset and excellent interpersonal skills to ensure that products of the highest quality serve our patients? Are you eager to play an important role in ensuring the quality and safety of products assembled by [xxxxx] worldwide? If so, we have an exciting possibility waiting for you as Senior QA in Assembly and IT in Finished Product Manufacturing Science and Technology Quality Assurance (FPMSAT QA). Apply now and start a life-changing career! The position In this role, you will work as a Senior QA covering assembly specifications for our worldwide production of finished products, and you will be part of a team of 13 engaged and highly skilled QA colleagues. Furthermore, you will be responsible for optimizing our IT systems in our local clinical production facility with tasks related to SAP, master data, and batch release processes. Your main responsibilities will be to:
  • Act as an Assembly QA guiding and approving assembly specifications for our pre-assembly and final assembly production used worldwide.
  • Guide and approve change requests and validation projects on our local clinical assembly production lines.
  • Guide and approve projects related to IT such as digital batch release, simplified master data flow, etc.
  • Act as a role model for QA colleagues in the department.
  • Support tasks related to the Quality Management System and process groups.
    • Depending on your level of experience and ability to act across different subject matters, you will contribute to improvement projects both internally with our stakeholders and across the [xxxxx] Quality organization. Qualifications The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions, and follow-up on quality-related problems. To succeed in this role, you:
  • Have a minimum of a bachelor’s degree in Engineering, Pharmaceutical, Science, IT or other relevant field
  • Have 5 or more years of experience within a GMP regulated manufacturer, preferably in quality assurance.
  • Have experience with assembly/packaging processes and IT systems.
  • Are fluent in English.
  • Prior experience with medical devices and combination products would be an advantage.
    • On a personal level, you are ambitious and ready to take responsibility for building strong competencies within our team and fostering trustworthy relationships across the organization. You can use your excellent cooperation skills to manage your stakeholders and ensure solutions that meet both requirements and stakeholder interests. You want to make a difference and are eager to learn. Finally, you are well-organised and have a flexible, but firm approach when making decisions. About the department At FPMSAT QA, we are a team of 40+ highly qualified professionals based at our Hillerød site, with diverse backgrounds and interests. We are responsible for ensuring the quality and compliance of all processes in FPMSAT, including product development and life cycle management, design control, testing, manufacturing development, and manufacturing processes. We take pride in our work and constantly seek to improve our competencies and processes by focusing on simplicity and collaboration. By joining our department, you will have the chance to make a real difference in the lives of patients through the development and life cycle management of crucial medical devices. 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 Manager Nikolaj Jespersen at +[xxxxx]. Deadline 7 April 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 CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. Applications will be evaluated continuously as they are received, and candidates may be called for interviews before the deadline. 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 24.3.2025, 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.
    • 24.03.2025
    • Øvrige
    • Hillerød
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