Microbiologist

Cedarparktexasedc; Austin (TX); Presencial; USD 65 000 - 90 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Microbiology

Technical writing

Microsoft Office

Formação académica

Bachelor's degree in microbiology or biology

Ferramentas

ISO 13485

Descrição da oferta de emprego

Position Information

Job Title: Microbiologist

Reports To: Head of Biocompatibility and Sterility

Location: Austin, TX

Business Unit: 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

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.