Quality Engineer (HU)

Quality Engineer (HU)

This position contributes to ensuring conformity of Omixon’s products to customer and regulatory requirements and maintaining effectiveness of the quality management system and report to RAQS (Regulatory Affairs and Quality System) manager


  • Ensure verification of supplied products according to set requirements
  • Handle supplier quality problems, tracking of actions, provide data for supplier evaluation
  • Contribute to problem solving and continual improvement processes by CAPA (Corrective Action, Preventive Action) management
  • Collect data and create statistics and report on product and process performance
  • Monitor complaint handling process, evaluate complaints and take part in investigation
  • Perform internal and supplier audits according to yearly audit plan
  • Maintain QMS documentation related to his role
  • Provide quality training company wide
  • Technical file management
  • Participate in product and process risk assessment
  • Contribute to CE marking and other regulatory approval of Omixon products
  • Keep up to date with new standards and regulatory requirements
  • Communicate and cooperate with other departments during his work

Required qualifications (education, experience, and skills)

  • MSc/BSc in Engineering (Chemical-, Bioengineering) or Life sciences
  • Experience in EU and/or US (FDA) regulation for (IVD) medical devices
  • Experience in ISO 13485:2016 standard application
  • Advanced English
  • Strong knowledge of Microsoft Office tools
  • Minimum 2 years experience in the field of Quality Management

Profile requirements

  • Interested in bioinformatics/biology/medical software testing
  • Quick learner, eagerness to learn and improve
  • Able to work independently
  • Result oriented, precise, and persistent personality
  • Excellent analytical, data analysis skill
  • Good communication and interpersonal skills

What we will provide you

  • Flexible working hours
  • Home office work
  • Competitive salary and performance-related annual bonus
  • Cafeteria with optional elements (Gross 45.000. HUF per month)
  • Laptop
  • Free coffee and beverages
  • Free parking
  • Pleasant office and family atmosphere
  • Challenging and innovative work
  • We care for your work-life balance
  • Company events

Start Date: ASAP
Type of Position: Full time
Base Location: H-1117 Budapest, Kaposvár u. 14-18.

Our company culture builds connections, careers and employees grow by creating a workplace that values flexibility, autonomy, and transparency.

Sounds just like you?

Please send us your CV with your Gross salary expectations and possible start date