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Senior Quality System Engineer - Genève


  • A hirdetés 723 napja lejárt
Your role

• You provide leadership and guidance related to area of responsibility CAPA, internal and external audits
• You drive and manage project development from A to Z
• You carry out internal and external system audits, internal trainings for audits and CAPA, corporate or distributors system audits on request and product audits on request
• You manage track action items from audits
• You develop and implement quality systems strategies to improve the performance of the quality system
• You develop metrics for determining effectiveness of applicable quality systems and develop plan to address improvements as identified
• You identify quality system issues and improvements and create plans to solve and implement with various operational groups
• You support operation, maintenance, monitoring and further development of the process oriented organizational system
• You plan and schedule Management Review Meetings and Quality Trending Meetings
• You maintain and revise applicable procedures (CAPA, Audits, Quality Trending) as necessary


Your profile

• You possess a post-secondary school education and qualification in a technical discipline, preferably engineering, physical or biological science (additional 8 years' experience could replace it)
• You have 6 years' experience in quality management, preferably CAPA and Audits within the medical device business
• You have knowledge of applicable Regulations and Standards, in particular ISO13485, ISO14971, the Medical Device Directive 93/42/EEC, US Quality System Regulations (QSR) and Canadian Regulation (CMDCAS)
• You are familiar with office software packages
• You possess the independent decision making ability and the ability to interpret and apply regulations and standards (ISO, QSR, ...) as appropriate
• You have the ability to analyze quality system projects and develop project plans to achieve successful implementation of systems
• You must be knowledgeable in the regulatory requirements for the key quality system elements in order to maintain compliance and drive improvements needed to support business needs
• You must be able to balance priorities among many ongoing tasks, and be responsive ti critical situations
• You have the ability to effectively prioritize and execute tasks in a high-pressure environment
• You must have excellent written and oral communication skills in German and English
• Travel requirements: around 5%

If you would like to hear more about this job then please don't hesitate to send your CV to or reach us out at .
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Helyek Külföld
Kategória Külföldi munka
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