Microbiologist

Enovis•Austin, TX

2d•Onsite

About The Position

As a key member of the Quality Assurance department, this role plays an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. The position involves performing activities for sterilization validations, processing of reusable devices, generating protocols, coordinating with test labs, and authoring technical reports. The Microbiologist will also manage the dose audit program and annual sterilizer requalification, support product development for new implants, and conduct routine monitoring of water systems, cleanrooms, and product bioburden. Responsibilities include interpreting microbiological cultures and other tests, supporting process or design changes, ensuring compliance with FDA and ISO standards, and assisting with regulatory submissions.

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