Quality Engineer (HU)

Quality Engineer

The Quality Engineer contributes to ensuring conformity of Omixon’s products to customer and regulatory requirements, maintaining effectiveness of the quality management system and report to RAQS manager.

 

Your Responsibilities In This Position Are To

  • 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: raise CAPAs, tracking actions, drive CAPA meetings, take meeting minutes
  • Collect data, create statistics and report on product and process performance
  • Monitor complaint handling process, evaluate complaints and take part in investigation
  • Substitute RAQS manager in his absent as a member of the Compliance Committee in case of potential adverse event and regulatory issues
  • Provide weekly status updates for RAQS manager
  • Perform internal and supplier audits according to yearly audit plan
  • Maintain QMS documentation related to this role
  • Provide quality training company wide
  • Manage Technical files
  • Participate in product and process risk assessment
  • Contribute to CE marking and other regulatory approval of Omixon products
  • Monitor standards, regulatory requirements
  • Communicate and cooperate with other departments
  • Follow quality service standards and comply with procedures, rules and regulations
  • Work according to the Omixon IT security policy description

Required Skills and qualifications

  • Interested in bioinformatics/biology/medical software testing
  • Quick learner
  • Able to work fairly independently
  • Result oriented, precise and persistent personality
  • Excellent analytical, data analysis skill
  • Good communication and interpersonal skills
  • Msc/Bsc in Engineering and/or Life sciences
  • Knowledge on medical device or pharmaceutical regulation
  • Advanced English
  • Strong knowledge of Microsoft Office tools
  • Quality engineer experience, knowledge of quality tools (FMEA, 8D, SPC etc) is an advantage

What We Will Provide You

  • Modern office and environment
  • Challenging tasks in an innovative industry
  • Flexible working hours
  • We care for your work / life balance
  • Competitive salary
  • Company events

 

Start Date: ASAP
Type of Position: Full time
Base Location: H-1117 Budapest, Fehérvári út 50-52

Sounds just like you?

If you are keen on joining this exciting, forward thinking company and taking the next step in your career, then please send us your CV in English with your Gross salary expectations and possible start date to jobs@omixon.com

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