Beschreibung
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:
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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