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水平: Entry level
工作类型: Full-time
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工作内容
Our client, an innovative company within medical devices industry in Lausanne is looking for aQuality Assurance Engineer
Start: Asap
Permanent employment
Your Mission
- Continuously improve the company quality system by analyzing KPIs and data such as complaints, non-conformances, CAPAs etc., reporting trends and providing solutions to any quality and technical issues affecting compliance
- Proactively investigates, identifies, and implements best-in-class Quality Assurance practices in regulated industries
- Be responsible for development, preparation, collation or control of all CSV documentation to deliver continued compliance with ISO13485 standard and FDA / EU Regulations
- Interface directly with IT, Engineering and Vendors to develop CSV strategy
- Provide support for quality system processes and best practices
- Provide Quality compliance expertise and support as required by the organization
- Create or review documents prepared by stakeholder (e.g. plan, protocols, reports, change controls)
- Assist in resolution of deviations/ exceptions during qualification activities
- Oversee and administer document lifecycle management as well as the Document Change Request process
- Perform final approval of documents submitted through the change control process for format, completeness and review
- Handle company Quality Audit process
- Conduct QA-RA intelligence/research to maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards
- Conduct training on quality assurance concepts and tools to the organization
- Managing the site calibration program, the coordination of calibration activities and associated documentation.
- Bachelor of Science in an engineering or applied science discipline
- 2-5 years’ experience in the healthcare industry
- Detailed knowledge of FDA Quality Systems Regulations, ISO 13485, 21 CFR part-11 and other global regulations and standards
- Experience with statistical analysis concepts and techniques
- Advanced personal computing skills and familiarity with a variety of business software packages including Office, Atlassian tools, ERP and able to learn new technologies quickly
- Fluent in English (level C1) with minimum B2 level in French
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最后期限: 08-06-2024
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