обновлено 14 дней назад
Microbiologist (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Microbiologist (Medical Devices): Performing sterilization validations and microbiological evaluations for reusable devices and new medical implants with an accent on sterility, cleanliness, and environmental monitoring. Focus on designing testing strategies, interpreting microbiological assays, coordinating laboratory work, and assuring compliance with FDA and ISO standards.
Location: Austin, Texas, USA
Company
is a medical technology company developing clinically differentiated solutions for orthopedics and related healthcare applications.
What you will do
- Perform sterilization validations for gamma, VHP, and H2O2 gas plasma processes.
- Evaluate cleaning, disinfection, sterilization, and processing of reusable medical devices.
- Generate protocols, coordinate testing laboratories, and author technical reports.
- Manage dose audits, annual sterilizer requalification, water system monitoring, cleanroom environmental monitoring, and product bioburden programs.
- Support new implant development, product and design changes, and supplier changes by defining sterilization, cleanliness, and microbiological testing strategies.
- Interpret cultures, sterility tests, microbial assays, cytotoxicity testing, chemical characterization, and environmental monitoring results while supporting regulatory submissions.
Requirements
- Bachelor’s degree in microbiology, biology, or a related field.
- At least 1 year of relevant experience.
- Experience in medical devices or another highly regulated industry.
- Knowledge of technical writing quality and best practices.
- Knowledge of Microsoft Office Suite or equivalent software.
- Knowledge of ISO 13485 is preferred.
Culture & Benefits
- Quality Assurance role focused on scientific excellence and improved patient outcomes.
- Medical, dental, and vision insurance.
- Spending and savings accounts, income protection plans, and discounted insurance rates.
- 401(k) plan.
- Vacation, sick leave, holidays, and legal services.
- No travel required.
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