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2 jobs found in Lausanne, Vaud

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    • lausanne, vaud
    • permanent
    Our client, an innovative company within medical devices industry in Lausanne is looking for a  Quality Assurance Engineer Start: AsapPermanent 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. Education & Skills:• 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 Language skills:• Fluent in English (level C1) with minimum B2 level in French 
    Our client, an innovative company within medical devices industry in Lausanne is looking for a  Quality Assurance Engineer Start: AsapPermanent 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. Education & Skills:• 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 Language skills:• Fluent in English (level C1) with minimum B2 level in French 
    • lausanne, vaud
    • temporary
    Do you have several years of experience in quality in the medical industry ? Do you like to take part in multi team projects ? You should then read the following description!For one of our clients, we are looking for a Global Product Development Quality Lead, for their site in the Lausanne area. The mission is to last from 01.03.2022 until the end of Jan 2023. Tasks:Lead the Quality Management System (QMS) for Combination Products (CP) across different departments.Ensure quality of product development through Good Manufacturing Practices (GMP) or relevant requirements.Secure compliant product availability to patients and consumers for (pre-)clinical/claim studies.Reviewing/approving quality deliverables related to products in development within manufacturing facilities as well as CDMOsProviding quality expertise on GDP/GMP/ISO requirements during product early and late clinical phasesQuality representative in product development projectsProviding support for product transfers to commercial phaseEnsuring qualification of vendors used in development project Organizing/performing quality audits for products in developmentResponsible for QMS elements like IP complaints, deviations and CAPAsRegular meetings and collaboration with main stakeholders (CMC Project Managers, Regulatory, Clinical Supply Representatives, Clinical Project Managers and commercial QA)Quality Representative in MD division including following duties/responsibilities:responsible for Quality Control and Quality Assurance activities used to ensure processes are sufficient to detect and control nonconformities encountered during design and manufacturing maintaining Quality Manual, QMS policies, procedures, and work instructions for MDs and Combination Productssupervising operational quality activities (Change Controls, Nonconformities, Development Reviews….) for MD and Combination ProductsProfile:University degree in Science including Chemistry, Biology, Pharmacy, Engineering.Advanced courses on GMP/GDPExperience in the pharmaceutical/biotech/medical devices industrySolid background in QualityProject management skillsRegulatory inspection experience Those lines sound familiar and appealing to you ? Apply now!
    Do you have several years of experience in quality in the medical industry ? Do you like to take part in multi team projects ? You should then read the following description!For one of our clients, we are looking for a Global Product Development Quality Lead, for their site in the Lausanne area. The mission is to last from 01.03.2022 until the end of Jan 2023. Tasks:Lead the Quality Management System (QMS) for Combination Products (CP) across different departments.Ensure quality of product development through Good Manufacturing Practices (GMP) or relevant requirements.Secure compliant product availability to patients and consumers for (pre-)clinical/claim studies.Reviewing/approving quality deliverables related to products in development within manufacturing facilities as well as CDMOsProviding quality expertise on GDP/GMP/ISO requirements during product early and late clinical phasesQuality representative in product development projectsProviding support for product transfers to commercial phaseEnsuring qualification of vendors used in development project Organizing/performing quality audits for products in developmentResponsible for QMS elements like IP complaints, deviations and CAPAsRegular meetings and collaboration with main stakeholders (CMC Project Managers, Regulatory, Clinical Supply Representatives, Clinical Project Managers and commercial QA)Quality Representative in MD division including following duties/responsibilities:responsible for Quality Control and Quality Assurance activities used to ensure processes are sufficient to detect and control nonconformities encountered during design and manufacturing maintaining Quality Manual, QMS policies, procedures, and work instructions for MDs and Combination Productssupervising operational quality activities (Change Controls, Nonconformities, Development Reviews….) for MD and Combination ProductsProfile:University degree in Science including Chemistry, Biology, Pharmacy, Engineering.Advanced courses on GMP/GDPExperience in the pharmaceutical/biotech/medical devices industrySolid background in QualityProject management skillsRegulatory inspection experience Those lines sound familiar and appealing to you ? Apply now!

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