Quality Engineer

Our partner is a globally recognised healthcare and manufacturing company producing medical device solutions for patients worldwide.

You will support and develop quality assurance processes within a manufacturing value stream, making sure medical device standards and regulatory requirements are met while driving improvement, supporting audits and keeping the Quality Management System effective.

• Maintaining and improving QA processes within your value stream
• Ensuring compliance with ISO 9001, ISO 13485, MDSAP, FDA and internal requirements
• Creating and updating QA documentation and supporting internal, external and regulatory audits
• Investigating customer complaints and coordinating CAPA and NCR activity
• Working with validation and calibration teams and delivering quality training

• A bachelor's or master's degree in Engineering or a related technical field
• At least 3 years in quality assurance, quality engineering or quality systems
• Experience in a regulated manufacturing environment
• Fluent Hungarian and advanced English
• Experience with CAPA, NCR, change control and FDA or MDSAP requirements is a plus

• A respectful, people-focused working environment
• Well-equipped, comfortable facilities
• Continuous training and career development
• Exposure to advanced medical device manufacturing technology
• The chance to work on products that improve patients' lives