Microbiologist, Sterility & Quality Assurance

enovis; Austin (TX); On-site; USD 62,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Job summary

Enovis, in Austin, TX, is seeking a Microbiologist to join the Quality Assurance team. You will support sterilization validation, bioburden monitoring, and regulatory submissions for medical devices.

The position requires a Bachelor’s in microbiology or biology with 1+ years of experience, preferably in a regulated environment, and familiarity with technical writing and Microsoft Office.

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.

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.

Education

Bachelor’s in microbiology or biology

Tools

Microsoft Office

Job description

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

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. Visit www.enovis.com to learn more.

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.

Join us in creating better together.

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.