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Hørsholm

    Details, standards, procedures, writing, and more details – are you ready to be the owner of our QMS? - Hørsholm, Danmark - Technolution

    Technolution
    Technolution Hørsholm, Danmark

    Fundet i: beBee S2 DK - for 1 dag siden

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    Fuldtid
    Beskrivelse

    As our QMS responsible, with at least 5 years of experience, you know your way around Pharma or MedTech standards, and you take pride in knowing every corner of the QMS.

    Don't be careful what you wish for
    Don't be careful what you wish for
    Because we are quite confident to be able to grant all your wishes. You will be part of a small and highly experienced Quality Management-team, and you will have an important, split role. First of all, you will be working with our clients facilitating efficient quality management within the Medical Device industry, specifically IVD and Combination Products.

    Besides that, you are going to upgrade our own QMS and help the process owners in Technolution. We work together, and there is always help and sparring within close range, if you should need it. As a consultant, you will work on diverse projects with start-ups to industry leaders, some days from the office in Hørsholm, some days onsite at the clients and some days remote. And by the way: being a consultant is not equivalent to being a lone wolf: you will always be part of a team.

    We have a few wishes too
    You have a minimum of 5 years of experience working with Quality Management in Pharma or MedTech, you have an intuitive understanding of how standards play out and how to apply them. You are very familiar with standards such as ISO 13485, EU and FDA regulations for MD, IVD and Combination Products. You find it natural to build good relations with clients and colleagues, because you probably already experienced that this approach creates the best results.

    • You have some prior experience with mechanical product development. Preferably in MedTech but this is not a must.
    • You have minimum B. Sc. degree in Mechanical Engineering or equivalent.
    • You are an expert user of CAD systems such as SolidWorks and Creo.
    • You have extensive knowledge about materials and production methods.
    • You are experienced in designing products of plastic and developing movable mechanics.
    • You are fluent in Danish and have excellent English skills.

    Should we meet?
    Want to do it the formal way, by sending an application or just start by having a cup of coffee and an informal chat?

    Both ways work for us, just drop us a line at and please state the name of the position in the header. You are also welcome to call Nancy Fonskov, Head of Quality at

    The way we work is our mark – tn
    We are a hub of knowledge, crisscrossing, and innovation. We are more than 70 nice and nerdy consultants – young talents and experienced professionals – working no more than 37 hours a week, always as part of a team and with no pressure for selling out competencies. What we share is a great team spirit, honesty, and respect – altogether fostering a great culture of good relationships.

    Meet Technolution
    Technolution is a growing consultancy within Pharma and MedTech teaming up with clients to develop innovative and life-improving medical devices. We are based in Hørsholm in charming surroundings, most of our clients are located near Copenhagen, and our colleagues are switching between on-site and remote work.

    Our ten areas of expertise enable us to assist our clients in all stages of the product development cycle, bringing high tech skills with a human touch. Over the past 20 years, Technolution has developed a culture of trust and professionalism, reflected in our increasing number of new and returning clients – from small startups to some of the largest players in the field.

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