Microbiologist

Microbiologist As a key member of the Quality Assurance department you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. Reports To: Head of Biocompatibility and Sterility Location: Austin, TX Business Unit Description: Quality Assurance Duties and Responsibilities: Performs activities for sterilization validations (gamma, VHP and H2O2 gas plasma) Performs activities for processing of reusable devices (cleaning, disinfection, sterilization) Generates protocols, coordinates with test labs, and authors technical reports Manages dose audit program and annual sterilizer requalification Support product development for new implants for sterilization and cleanliness evaluation, including define testing strategies Routine monitoring and control of water system, ISO Class 7 cleanroom environmental monitoring and product bioburden Reads and interprets microbiological cultures and other tests including environmental monitoring, sterility tests, chemical characterization, cytotoxicity testing and microbial assays Support process or design changes for existing products and supplier changes for sterilization, cleanliness and processing evaluation, including define testing strategies Assures compliance to FDA and ISO standards Assists in generation and response for regulatory submissions Perform other job duties as needed Minimum Basic Qualifications: Bachelor's in microbiology or biology and 1+ years of relevant experience. Background in Medical Device, or other highly regulated industry required; preferred knowledge of ISO 13485. Knowledge of technical writing quality and best practices. Individual should have knowledge of Microsoft Office Suite of software or equivalent. Travel Requirements: None We offer a comprehensive benefits package that includes: Medical Insurance Dental Insurance Vision Insurance Spending and Savings Accounts 401(k) Plan Vacation, Sick Leave, and Holidays Income Protection Plans Discounted Insurance Rates Legal Services Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis. Enovis