(Sr) Quality Engineer Sterilization and Contamination Control (80-100%)

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

The Sterilization and Contamination Control department in Bülach, Zürich delivers the application and practice of microbial assurance as applied to the design, manufacture, and sterilization of implants while ensuring that the company meets all applicable standards and regulations requirements.

Your 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

Your Profile

• 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

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Bülach | Working hours: Full-time | Type of contract: Unlimited

Apply now under: www.biotronik.com/careers

Job ID: 61022 | Contact: Martina Micciulla | Tel. +41 75 429 56 23