Quality Manager, Teamleader QA

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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 MDSAPLeading and driving assigned initiatives within the project plus ensuring quality oversight with strong quality guidance, scientific and technical expertiseContributing to the strategy of assigned projects including contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverablesUnderstanding and proactively managing the interactions between the project organisation and the key involved functions and stakeholdersProviding 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 fieldPractical 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 softwareExcellent scientific, technical and regulatory knowledge in a specific areaKnow-how of cGMP, working knowledge of medical device software regulations, standards and guidelines

Your soft skills: Capability to influence people, negotiate and communicateStrong organisational skills

Location: Stein, Switzerland Sector: Pharma

Start: 02/2022

Duration: 11MM+

Ref.Nr.: BH18046

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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.

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