Microbiologist Job at Enovis, USA | Sterility and Quality Assurance | Apply Online
How do medical device teams verify sterilization processes and monitor contamination risks? This microbiologist job at Enovis in Austin, Texas, USA, combines sterilization validation, cleanroom monitoring, and microbiological testing. The full-time role suits Biology or Microbiology graduates with at least one year of relevant experience and a background in medical devices or another highly regulated industry.
- Position: Microbiologist, Sterility & Quality Assurance
- Location: Austin, Texas, USA
- Job Requisition ID: R0033565
- Department: Quality Assurance
- Reports To: Head of Biocompatibility and Sterility
About The Company
Enovis is a medical technology company developing products, services, and integrated technologies in orthopedics and beyond. Its work focuses on improving patient outcomes and clinical workflows through innovation, collaboration, and continuous improvement.
Microbiologist Job Description
The Microbiologist will support the Quality Assurance department through sterilization validations, reusable device processing evaluations, and contamination monitoring. The role involves preparing protocols, coordinating with testing laboratories, and writing technical reports.
The selected candidate will also help define testing strategies for new implants, existing product changes, and supplier changes, supporting compliance with FDA and ISO standards.
Microbiologist Job – Key Responsibilities
- Perform sterilization validation activities involving gamma, vaporized hydrogen peroxide (VHP), and hydrogen peroxide gas plasma.
- Support cleaning, disinfection, and sterilization evaluations for reusable devices.
- Generate protocols, coordinate with test laboratories, and author technical reports.
- Manage the dose audit program and annual sterilizer requalification.
- Support sterilization and cleanliness evaluations for new implants, including defining testing strategies.
- Monitor water systems, ISO Class 7 cleanroom environments, and product bioburden.
- Read and interpret microbiological cultures and test results, including environmental monitoring, sterility, chemical characterization, cytotoxicity, and microbial assays.
- Evaluate sterilization, cleanliness, and processing requirements arising from product, process, design, or supplier changes.
- Support compliance with FDA and ISO standards.
- Assist with preparing regulatory submissions and responses.
Educational Requirements and Eligibility For Microbiologist Job
- Qualification: Bachelor’s degree in Microbiology or Biology.
- Experience: At least one year of relevant experience.
- A background in the medical device industry or another highly regulated industry is required.
Skills and Qualifications
- Knowledge of technical writing quality and best practices.
- Proficiency in Microsoft Office or equivalent software.
Preferred Knowledge: Familiarity with ISO 13485.
Benefits
Enovis offers medical, dental, and vision insurance, spending and savings accounts, a 401(k) plan, vacation, sick leave, and holidays. Additional benefits include income protection plans, discounted insurance rates, and legal services.
Interested in applying microbiology to medical device quality? This microbiologist job at Enovis offers work across sterilization validation, environmental monitoring, and regulatory documentation. If your qualifications and regulated-industry experience match the requirements, review the vacancy and submit your application.
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