Feladatok:
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.
- 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
- 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)
Elvárások:
- 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
Munkavégzés helye:
Munkavégzés helye
Pest vármegye