Beschreibung
Product Quality/Documentation Engineer
Our client seeks a Product Quality/Documentation Engineer to assist in the release of a diagnostic device. In this role your focus will within the area of system testing.
Following tasks:
Ensure and review the product documentation as part of the design "History Clean Up Project"
Creating, updating, filing and inputting of the following documents in accordance with product development
Process and guidance:
- Test Specifications
- Production Specification
- Instrument Validation master plan
- Qualification Qualification Tests + master report
- Process FMEA
- Instrument Validation Master Report
- Test Equipment Qualification/Validation Report
- Manufacturing and Test Instructions
- Work Instructions Production Documentation
- Techical delivery condition
- Manufacturing Flow Chart
- carry out the technical reviews of CAPA and change tasks
- Expert advice and support from staff and colleagues in the product team
Requirements:
- Training
- you are Ingeneur FH with several years of experience in the documentation of production processes; or scientists/biotechnologist from university or college with a bachelor,
Experience
- structured, scientific approach is natural for you, as well as a
- strong quality awareness and understanding of complex hardware and software architectures IT
Languages
-Good communication skills in German and English (written and spoken)
If you think that you are the ideal candidate for this position please send a copy of your CV as a Word Document and a daytime contact telephone number. Please note that applicants must be eligible to qualify for a work permit in the specified location.