Beschreibung
Role:- conduct product testing of medical evices using approved method
- document the outcome of all tests in compliance with regulatory requirements
- manage test equipment and ensure that it is maintained and calibrated in compliance with requirements at all times
- work with product development engineers to ensure that products are designed with consideration of testing requirements
Requirements:
- experience in functional testing of medical devices
- knowledge of statistical tools related to Measurements System Analysis such as GR&R, Gage Linearity and Bias, Attribute Agreement Analysis, Kappa Statistics, Control Charts, etc.
- knowledge and experience with measurements sytem analysis
- sample collection experience (destructive and non-destructice tests)
- development of test method instructions
- proficient in minitab software
Qualification:
- higher level degree / Level 8 qualification in Engineering / Quality / Science
- minimum 5 years experience working in a product testing, preferably in medical devices new product development
- fluentgerman and english
- working in an FDA regulated environment
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