33 jobs en Biologie / Biotechnologie à Lausanne

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QA Specialist - Night shift

12 mai | Employé | 100%

QA Specialist - Night shift

For our client specialized in medical devices, localized in the French part of Switzerland, we are looking for a :

QA Specialist - Night shift

Your responsibilities

  • Guarantee the application of ISO13485 norms, 21CFR part 820 and other applicable regulations
  • Ensure conformity of good manufacturing practices and internal QMS
  • Support and manage quality events related to production operations (incident report, non-conformances)
  • Participate to investigations to identify root cause and to product impact analysis
  • Define corrections, corrective and preventive actions to prevent reoccurrence of events and support for implementation in production
  • Identify possibility for improvements for production processes and for related documentation
  • Ensure follow-up of his activities and provide KPIs
  • Ensure training steps related to your scope of activities
  • Contribute to quality assurance documentation (release documents, records) related to your scope of activities
  • Participate to continuous improvement and pro-actively adopt a solution-based approach
  • Prepare and support QA Team during audits & inspections
  • Ensure back up of other QA Team members
  • Support and promote the diffusion of a high-quality mindset in the company

Your profile

  • Scientific education
  • Professional experience in Quality Assurance for Medical Devices
  • Knowledge of the main Quality System Management regulations for Medical Devices (21 CFR part 820 & ISO13485) and GMP environment
  • Professional experience in Medical Device Company having a production environment
  • Fluent in French,
  • Basis in German and/or English

Your application Please apply on-line. For more information, contact Ms Sophie Darthenay