Quality Assurance supervisor (OEM, equipment)

Gold Standard Diagnostics

  • Budapest
  • Állandó
  • Teljes munkaidő
  • 3 napja
Gold Standard Diagnostics is an International Business Line (IBL) focused on the development, manufacturing and marketing of bioanalytical technologies and diagnostic test kits. The business line is primarily focused on solutions in Food and Environmental Safety with some expansion into Animal Health and Clinical Diagnostics. The company serves both external customers (industrial laboratories, governmental laboratories, service laboratories) as well as customers within the Group.Working location: Budapest, IV. district
www.goldstandarddiagnostics.com,The Quality Assurance Supervisor is member of Quality Management’s Quality Assurance Team and reports to the Quality Manager. The overall objective of the role is to perform quality assurance tasks for all production teams, improve processes, makes decisions regarding material and product quality, review the production processes and ensure successful product release on a higher level. The Quality Assurance Supervisor supports the creation of quality documents and reviews them, moreover takes part in the handling and investigation of local non-conformities.POSITION OBJECTIVES:
  • Designated areas: OEM products and distributed laboratory equipment
  • Integrated ISO standard management at the designated areas: ISO 9001, ISO 13485, ISO 14001;
  • Creating, handling, improving and approving of quality documents on the designated areas (higher level: procedures, authority and customer letters; lower level: operation protocols, batch documents, forms, quality records etc.);
  • Supervision of non-conformity and complaint investigations, corrective actions (CAPAs) for the units;
  • Supervision of process management, work-flows, area control and improvements for the unit;
  • Taking part in validation and development of new production and control processes as part of the transfer activities;
  • Taking part in change management;
  • Assisting in training material preparation and trainings;
  • Performing internal audits;
  • Audit compliance, preparation and follow-up actions;
  • Working together with the involved production and supporting units;
  • Performing final quality reviews and batch documentation release;
  • Take part in new product development projects and product lifecycle activity as quality supervisor, with focus on the application of design controls such as design inputs definition, execution of design verification/validation and creation of design outputs;
  • Ensure completeness, robustness, and adequacy of quality documentation related to R&D and Design Transfer (handling, review/approval and improvements)
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  • University degree (BSc or MSc) in a related discipline (Chemistry, Biology, Biotechnology or similar)
  • 1-3 years of experience in Quality Management/Quality Control
  • English, Hungarian language knowledge (advanced communication and writing level)
  • Experience with ISO standards: 9001, 13485, 14001
  • Experience in MS Office usage
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  • Residence in Budapest / nearby of Budapest
  • preferred experience in reagent/chemical manufacturing field
  • experience with the designated unit’s product portfolio and technology
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  • Developing, stable employment background
  • Permanent, full time (40 hours per week) employment relationship
  • Various tasks and projects
  • An enthusiastic and frendly team and work environment, with a positive energie await you
  • Corporate events
  • SZÉP card allowance
  • Sport pass with employer discount
  • Private health service
  • Fruit day, free coffee, refreshments

Profession