Director of Endoscopy Reprocessing – Infection Control

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FUJIFILM Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1934

🏭 Manufacturing

🏥 Healthcare

Manufacturing • Healthcare • Electronics

FUJIFILM Corporation is a global company established in 1934, operating in diverse fields including healthcare, electronics, and imaging. As a total healthcare company, FUJIFILM develops a wide range of businesses in prevention, diagnosis, and treatment. Additionally, the company focuses on environmental sustainability through improved industrial efficiency, while also capturing and preserving memories through film and photography, enriching emotional lives and human connections.

📋 Description

• Manage reprocessing and infection control activities associated with the endoscopic product portfolio • Serve as the primary company resource and subject matter expert for cleaning, high-level disinfection, and/or sterilization of Fujifilm endoscopy products • Collaborate with headquarters liaisons, customers, third-party companies, sales, field personnel, international liaisons, marketing, and R&D teams in Japan • Develop and/or support validation programs for endoscope designs and reprocessing instructions • Support FDA requests and requirements, including 522 Postmarket Surveillance Studies and Human Factors Testing • Develop and revise endoscope operation and reprocessing manuals and improve product labeling • Develop policies, policy statements, and customer and sales representative notifications regarding infection control and reprocessing • Establish educational tools and review training aids on reprocessing and infection control practices • Support development and maintenance of luminary customers in key US target markets • Represent the company on national committees and at meetings and seminars developing reprocessing guidelines • Monitor and communicate new reprocessing and infection control trends and guidelines to Fujifilm Tokyo • Work with AER and sterilizer OEMs to validate and expand reprocessing options • Oversee/manage the HCUS Clinical Education Manager responsible for reprocessing training • Comply with U.S. FDA medical device regulatory requirements, ISO standards, and applicable laws and regulations

🎯 Requirements

• Bachelor’s degree in biology or microbiology is required • Minimum of 10-12 years’ experience in medical device reprocessing, validation studies, and infection control best practices • Strong background with flexible endoscopes • Extensive cleaning/reprocessing knowledge of medical devices is required • Background/experience working with the FDA • Knowledge of the biological evaluation of medical devices (biocompatibility) • 3-5 years’ experience as an accredited microbiologist is preferred • Proficient computer skills using Word, Excel, and PowerPoint • High command and literacy in endoscopic application • Strong analytical and critical thinking skills • Exceptional communication, interpersonal, analytical, and problem-solving skills • Ability to work independently and in a close team environment • Effective time management skills • Ability to read, analyze, and interpret essential job-related documents • Ability to present and speak effectively and professionally to internal and external customers • Ability to meet physical demands including standing, walking, keyboard use, reaching, balancing, stooping, kneeling, crouching, and talking/hearing • Ability to occasionally lift and/or move up to 30 lbs • Ability to meet required vision capabilities including close, distance, color, and depth vision and focus adjustment • Willingness to travel 30-50% depending upon business needs • Ability to comply with facility vendor credentialing requirements, including vaccine requirements where applicable • Willingness to periodically test for COVID-19 and wear a face covering indoors as required, subject to legally required accommodations

🏖️ Benefits

• Flexible work environment • Remote work • Equal opportunities in hiring, promotion and advancement, compensation, benefits, and training • Reasonable accommodation in the application and employee selection process • COVID-19 vaccination encouraged • Periodic COVID-19 testing and indoor face covering as required, subject to legally required accommodations