Sterility & Quality Microbiologist — MedTech QA

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

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.