Vas megye,

Quality System Engineer

Reference number WHCSZ12902
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Vas megye Back Quality System Engineer Reference number WHCSZ12902

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We are looking for a Quality System Engineer for our partner who manufactures medical technical aids in Vas County!

Tasks

  • Ensures with his/her supervisor that the requirements of the relevant standards and guidelines are dealt with: relevant cGMP, ISO 9001 - Quality Management System (QMS), ISO 15378 - Primary Packaging Pharmaceuticals, ISO 13485 - Medical Devices, pharmacopoeias and other guidelines in the pharmaceutical environment.
  • ISO 9001, ISO 15378, ISO 13485 - maintenance of certification status, monitoring of requirements, taking actions Participation in improvements, preparation for the audits, maintenance of the documents, managing changes.
  • Support for planning and conducting internal audits, creating (+following up) the associated audit reposts and CAPA items, creation and monitoring / updating of the annual Internal Audit Program.
  • Owner of CAPA management tool (software for CAPA management) and the related process. Issuing CAPAs, reviewing and approving CAPA results.
  • Supporting maintenance of Document management system based on the Process Map.

Expectations

  • BSc or MSc in the field of any engineering or nature science, quality management, food or pharmaceuticals
  • Quality experience in a manufacturing environment, minimum of 5 years in Quality Management System
  • Good command of English
  • Deviation and problem solving skills
  • High proficiency in QMS standards, including ISO 9001; advantage: ISO 13485, ISO 15378 GMP and other pharmaceutical guidelines, SAP
  • M365 knowledge
  • Experience regarding auditing (internal or supplier) 

Our offer

  • Multinational atmosphere
  • Competitive salary
  • Bonus twice a year
  • Flexible work schedule
  • Home office opportunity
  • Excellent commuting support
We are looking for a Quality System Engineer for our partner who manufactures medical technical aids in Vas County!
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