Our partner is a globally recognized medical device manufacturer with decades of experience and a strong focus on innovation and high-quality production standards. The Hungarian site plays an important role in the company’s global quality engineering and manufacturing processes.

Tasks

• Execution of validation and testing activities according to quality requirements
• Validation and qualification of manufacturing and testing equipment
• Supporting the preparation of validation protocols, reports, and maintenance procedures
• Identifying and documenting potential process or equipment gaps
• Performing validation tasks to support manufacturing technologies and products
• Conducting installation, operational, and performance qualification studies
• Ensuring critical operating parameters remain within qualified limits
• Implementing equipment enhancements in line with quality expectations
• Documenting deviations and investigations related to MDR remediation tasks

Requirements

• Experience in quality validations within a manufacturing environment, preferably medical device
• Proficiency in validation testing and statistical process control/monitoring
• Understanding of medical device standards and regulations
• Ability to prepare technical documentation and reports
• Strong statistical and mathematical skills
• Solid problem-solving abilities and systems thinking
• Intermediate level knowledge of Excel, Word, and PowerPoint (advanced is an advantage)

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