Microbiologist

Enovis • Austin, TX

1d • Onsite

About The Position

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. 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.

Requirements

• Bachelor’s in microbiology or biology and 1+ years of relevant experience.
• Background in Medical Device, or other highly regulated industry required
• Knowledge of technical writing quality and best practices.
• Individual should have knowledge of Microsoft Office Suite of software or equivalent.

Nice To Haves

• preferred knowledge of ISO 13485.

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level