Microbiology Specialist: Sterilization & QA for Med Devices

Enovis; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Enovis in Austin, TX seeks a Microbiologist to join the Quality Assurance unit. The role focuses on sterilization validations, processing of reusable devices, and developing testing strategies for implants.

You will generate protocols, coordinate labs, and prepare technical reports to support regulatory submissions. Requirements include a Bachelor's in microbiology or biology with at least 1 year of relevant experience, and knowledge of ISO 13485 in a highly regulated environment.

Qualifications

• Bachelor's degree in microbiology or biology with 1+ year of relevant experience.
• Background in Medical Device or highly regulated environments; ISO 13485 knowledge preferred.
• Strong technical writing skills and familiarity with Microsoft Office.

Responsibilities

• Perform sterilization validations (gamma, VHP, H2O2 gas plasma).
• Process reusable devices (cleaning, disinfection, sterilization).
• Generate protocols, coordinate with test labs, and author technical reports.
• Manage dose audit program and annual sterilizer requalification.
• Support product development for implants sterilization and cleanliness testing strategies.
• Monitor water system and ISO Class 7 cleanroom environmental monitoring and bioburden.

Skills

Microbiology

Technical writing

Microsoft Office

Education

Bachelor's degree in microbiology or biology

Tools

ISO 13485

Job description

Enovis in Austin, TX seeks a Microbiologist to join the Quality Assurance unit. The role focuses on sterilization validations, processing of reusable devices, and developing testing strategies for implants.

You will generate protocols, coordinate labs, and prepare technical reports to support regulatory submissions. Requirements include a Bachelor's in microbiology or biology with at least 1 year of relevant experience, and knowledge of ISO 13485 in a highly regulated environment.