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About the Role
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.
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
Requirements
- 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.
Location
- Austin, TX
Work Type
- None
Experience Level
- 1+ years of relevant experience
Education Level
- Bachelor’s in microbiology or biology
Benefits
- 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
About the Company
- Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.
Equal Opportunity
- 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.