IT Quality Management

Quality Manager, Teamleader QA

Switzerland / Contract

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    Quality Manager, Teamleader QA vacancy for a globally operating Stein based company in the pharmaceutical sector.

     

    Your tasks:

    • Assisting and driving in the global TRD project organisation as well as working on the QMS adaptation for SaMD and MDSAP
    • Leading and driving assigned initiatives within the project plus ensuring quality oversight with strong quality guidance, scientific and technical expertise
    • Contributing to the strategy of assigned projects including contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables
    • Understanding and proactively managing the interactions between the project organisation and the key involved functions and stakeholders
    • Providing expertise and supporting on SaMD and MDSAP to the project organisation and providing direct support to the relevant project work streams

         

    Your experience/knowledge:

    • 3+ years of relevant work experience within the given field
    • Practical expertise in managing projects in compliance with ISO 13485, 21 CFR part 820 and part 4, MDSAP, IEC 62304, IEC 82304, ISO 14971, IEC 62366, MDD/MDR, GDPR as well as other relevant standards and guidance related to medical device software
    • Excellent scientific, technical and regulatory knowledge in a specific area
    • Know-how of cGMP, working knowledge of medical device software regulations, standards and guidelines

     

    Your soft skills:

    • Capability to influence people, negotiate and communicate
    • Strong organisational skills

     

    Location:              Stein, Switzerland

    Sector:                 Pharma
    Start:                    02/2022
    Duration:              11MM+
    Ref.Nr.:                 BH18046

    Take the next step and send us your CV and contact phone number on which we can reach you during working hours.

    Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.

    By applying, you agree to the storage and processing of your data for the application process. We strictly comply with the applicable data protection laws.

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