Director of Endoscopy Reprocessing – Infection Control

FUJIFILM Corporation

Director overseeing endoscope reprocessing, sterilization validation, and infection control for Fujifilm’s healthcare imaging business. Supporting FDA compliance, product labeling, customer education, and global collaboration across Fujifilm teams.

Posted 8/17/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical device reprocessing, validation studies, and infection control practices, with a strong focus on compliance with FDA regulations and ISO standards. Proficient in developing educational tools and manuals for endoscopic products while effectively collaborating with cross-functional teams.

Highest-signal resume keywords

Medical Device ReprocessingValidation StudiesInfection Control Best PracticesFDA Regulatory ComplianceEndoscopic Application Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Biological Evaluation of Medical DevicesCleaning/Reprocessing KnowledgeMicrobiologyAnalytical SkillsCritical ThinkingProficient in WordProficient in ExcelProficient in PowerPointEndoscope Operation Manuals DevelopmentReprocessing Instructions Development

Soft Skills

Exceptional Communication SkillsInterpersonal SkillsProblem-Solving SkillsTime Management SkillsAbility to Work Independently

Industry Keywords

Infection ControlReprocessing GuidelinesISO StandardsFDA Medical Device RegulationsLuminary CustomersPostmarket Surveillance StudiesHuman Factors TestingAER and Sterilizer OEMsTraining AidsCustomer Notifications

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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