Beschreibung
VALIDATION ENGINEER/Medical Devices -
Purpose:
Independent planning and execution of all required activities for qualification/validation of equipment, special processes and production processes.
Independent creation of all required qualification/validation documents in cooperation with production, product development, design transfer and quality engineering
Serves as technical expert for the Validation process and responsibilities to ensure compliance
Ensure that all validation activities are carried out and reported in a timely manner
Ability to execute Validation processes and Testing
Must have:
3 Years proven qualification/validation experience in the medical devices production environment
Experience in Process Validation, Medical Devices, 21 FDA 820, ISO 13485
Engineering background
Fluent GERMAN and advanced English
Analytical, innovative and pragmatic thinking
Non-Technical profile requirements:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow change management for internal guidelines.
Language proficiencies:
English and GERMAN spoken and written;