(Sr) Quality Engineer Sterilization and Contamination Control / Microbiology (80-100%)
Join to apply for the (Sr) Quality Engineer Sterilization and Contamination Control / Microbiology (80-100%) role at BIOTRONIK Vascular Intervention.
Responsibilities
* To support the qualification and contamination control of medical devices in ISO Classified cleanrooms
* To support conduct, hygiene, gowning and cleaning regimes in controlled environments
* To support the validation of sterilization processes
* Test method development for bioburden, endotoxin, sterility testing and equipment qualifications within the laboratory
* To support New Product Development teams in the design of products with cleaning and sterilization in mind
* Perform failure, NC and CAPA investigations and implement required actions
Qualifications
* Degree level qualification in Medical/Mechanical Engineering, Biomedical Sciences, Microbiology or similar
* Minimum 2 years post qualification experience in sterilization and contamination control in a medical device, pharmaceutical, or similar regulated industry
* Knowledge of the following ISO Standards: 11135, 11137, 14160, 11737, 14644, 14698, 10993
* Fluent in German (minimum B2 level) and English
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Medical Equipment Manufacturing
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