Microbiologist, Sterility & Quality Assurance

Who We Are
ABOUT ENOVIS™
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. For more information about Enovis, please visit www.enovis.com.
What You'll Do
At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it.
Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself.
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.
Job Title:
Microbiologist
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
“Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.
What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors:
Our Enovis Purpose, Values and Behaviors on Vimeo
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
EQUAL EMPLOYMENT 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.