Overview
Quality Engineer Jobs in Budapest, Hungary at Omixon
Title: Quality Engineer
Company: Omixon
Location: Budapest, Hungary
About us
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Position Summary
This position contributes to ensuring conformity of our products to customer and regulatory requirements and support maintaining effectiveness of the quality management system and report to RAQS (Regulatory Affairs and Quality System) manager.
Key Accountabilities
- Ensure the quality and compliance of incoming materials, components, and supplied products.
- Manage supplier quality issues, coordinate corrective actions, track resolution progress, and provide input for supplier performance evaluations.
- Support problem-solving and continuous improvement initiatives through CAPA (Corrective and Preventive Action) management.
- Collect, analyze, and report quality data, creating performance metrics and statistics for products and manufacturing processes.
- Participate in the investigation of customer complaints, deviations, and nonconformities, identifying root causes and supporting corrective actions.
- Plan, conduct, and support internal and supplier quality audits to ensure compliance with applicable standards and requirements.
- Maintain and continuously improve Quality Management System (QMS) documentation related to manufacturing quality assurance.
- Develop and deliver quality-related training and guidance to manufacturing personnel, promoting quality awareness and best practices.
- Ensure the qualification and validation of manufacturing processes in accordance with regulatory and quality requirements.
- Support CE marking activities by overseeing design transfer controls and participating in product and process risk assessments.
- Monitor and interpret new quality standards, regulations, and industry requirements relevant to the area of responsibility.
- Collaborate effectively with cross-functional teams to drive quality excellence and support business objectives.
Minimum Knowledge & Experience required for the position
- 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
- 2-3 years experience in the field of Quality Management / Quality Assurance
- Interested in bioinformatics/biology/medical software testing
- Quick learner, eagerness to learn and improve
- Able to work fairly independently
- Result oriented, precise, and persistent personality
- Excellent analytical, data analysis skill
- Good communication and interpersonal skills
What we offer to you
- 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
Base Location: H-1117 Budapest, Kaposvár utca 14-18.
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 to [email protected].
