R&D Software Development

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3Shape is a global technology company headquartered in Copenhagen which offers unique career opportunities in the fields of Engineering, Software, Regulatory and QA.Our game is digital dentistry in the global market where we create value for our customers and improve the lives of patients like you and me.In 3Shape R&D we are proud of our empowered, team-centric working culture where you can be sure to meet highly skilled, educated, and diverse teammates (in our HQ alone we are 40 different nationalities).We have just formed a new Process and QA team in our R&D organization, and we are looking for THREE energised team members, with diverse experiences that can bring our vision to life.The positions are located at our HQ in Denmark; we are open to global applicants that are willing to relocate.The positionReporting to the Head of R&D Process and QA, your responsibilities will include:General QA Management
  • Ensuring compliance to all applicable quality standards and regulatory requirements.
  • Drive simplification and standardization of processes within the Quality Management System (QMS).
    • Supporting the implementation of our R&D processes
  • Work with project teams to facilitate the implementation of design control within product development and change projects.
  • Work closely with Regulatory Affairs to be that pillar of support for the organization to enable compliant document submission to authorities and successful regulatory audits.
  • Training and mentoring software and hardware engineers to engage with the processes, the QMS and continuous improvement activities.
  • Seek out opportunities to apply Lean principles and close potential compliance gaps.
    • Owning and driving “R&D Process and QA” projects and implementations
  • Regulations, standards, and requirements are constantly evolving. We, as an organisation, need to adapt when important changes occur. Examples could be managing the implementation of a new ISO standard or engaging with the role out of a new Learning Management System within the R&D organisation.
    • The need for project support will vary over time and the percentage of time spent on each of the workstreams described above may vary depending on business needs.QualificationsWe are looking for a person that has:
  • A hard working, team player with a positive mind-set and desire to add value
  • Excellent planning, cooperation, and communication skills
  • Experience working with compliance activities in a regulated environment, preferably with Medical Devices or Pharmaceuticals
  • Experience implementing medical device design control process is an advantage
  • Experience working with ISO 13485, ISO 14971, ISO 27001, FDA QSR or EU MDR is an advantage
  • A relevant educational background or experience in life sciences, engineering, or similar.
  • Proficiency in English as this is our working language.
    • We offerJoin one of the most exiting tech companies in the medical device industry and make a real impact. With us you will be able to work on solutions used by thousands of dental professionals worldwide! Moreover, we offer:
  • An attractive, international workplace in the center of Copenhagen, with highly skilled, diverse and committed colleagues in an informal work environment
  • A flexible and agile training and development process with the opportunity to influence and contribute to innovative products.
  • Many interesting challenges that will require your technical, analytical, and communicative skills
  • Participation in producing market leading technology products for customers around the world
  • Breakfast every day, and delicious and healthy lunch
  • We provide a great social work environment with many optional activities and employee clubs, ranging from wine, board games to bicycle clubs.
  • Work/life balance to keep you in tune with your interests e.g. possibility for remote work for up to 2 days a week
  • Opportunity to become part of the success that 3Shape has created over the past 20 years
    • Visit our website if you want to read more about our company, mission, or why 3Shape is a great place to workGet in touch now!If you are interested in this exciting opportunity, apply already today by clicking on "send application" and uploading your motivational cover letter and resume. We will review the applications continuously.
    We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community.About us3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Now, twenty years later, 3Shape is 1,700+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on Facebook.


    Information og data

    Denne ledige stilling har jobtypen "Softwareudvikler", og befinder sig i kategorien "Informationsteknologi".

    Arbejdsstedet er beliggende i København

    Jobbet er oprettet på vores service den 20.1.2022, 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.
    • Softwareudvikler
    • København
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