Quality Engineer – Validation & Inspection

Employment Type:Permanent
Job Location:Hungary
English Description:

Main Purpose of the Position

As directed by the Quality Manager, the Quality Engineer-
Validation & Inspection:

  • Responsible for Facility Qualification, Process and Software Validation and also provide support for Equipment & Instrument Qualification activities.
  • Responsible for incoming and final inspection
  • Responsible for the quality processes of supplier selection, approval and assessment

Primary Responsibilities and Duties

Validation:

  • Work in a team environment to identify resources (internal, external) and develops qualification plans & schedules
  • Manage the qualification schedule for the project and ensure deliverables are met and documented per the project plan and Validation master schedule
  • Ensure all related qualification documentation is fulfill business & technical requirements; all strategies, plans, protocols, completion reports or any type are complete, comprehensive, technically sound and accurate
  • Oversee authoring of qualification protocols, plans and reports as needed and review work of others.
  • Provide analytical and strong statistical support in setting up, collecting, analyzing, documenting, and presenting evidence of the qualification work.

Incoming and final inspection:

  • Leading the incoming and final inspection team
  • Ensure inspections are done according to the procedures
  • Ensure fulfill inspection KPIs
  • Manage inspection related issues, non-conformances and investigations

Supplier quality:

  • Lead supplier and some internal quality system audits as a means of evaluating the effectiveness of the established Quality System
  • Participate in supplier selection, approval and assessment process

Education/Degree:

  • Requires a minimum of a Bachelor’s Degree in engineering

 

Experience:

  • A minimum of 3 years relevant experience with quality assurance and validation   
  • Experience with biotechnology/laboratory/medical devices/pharmaceuticals, manufacturing processes and products.
  • Experience with hands-on validation planning & execution activities
  • Demonstrated experience in training on validation practices.
  • Applied knowledge of ISO9001 with ability to design, document and implement clear and straightforward processes and procedures
  • Effective Analytical & Statistical Skills (Minitab)
  • Experience with people management
  • SAP QM knowledge highly preferred
  • Experience with Supplier Quality Assurance process preferred
  • Strong communication, organizational and project management skills.
  • Fully bilingual – English – Hungarian (written and spoken)