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Director of Endoscopy Reprocessing, Infection Control
FUJIFILM CorporationDirector overseeing endoscope reprocessing, sterilization validation, and infection control for Fujifilm’s healthcare imaging products. Supporting FDA compliance, technical documentation, education, and clinical partnerships.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical device reprocessing, validation studies, and infection control best practices, with a strong focus on endoscopic products. Proficient in developing educational tools and compliance with FDA and ISO standards.
Highest-signal resume keywords
Medical Device ReprocessingInfection Control Best PracticesFDA ComplianceEndoscopic Application KnowledgeValidation Studies
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Biological Evaluation of Medical DevicesCleaning and Reprocessing KnowledgeAnalytical SkillsProblem-Solving SkillsProficient in Word, Excel, PowerPoint
Soft Skills
Exceptional Communication SkillsInterpersonal SkillsTime Management SkillsCritical Thinking Skills
Certifications & Qualifications
Bachelor’s Degree in Biology or MicrobiologyAccredited Microbiologist (Preferred)Master’s Degree (Preferred)
Industry Keywords
Reprocessing GuidelinesHigh-Level DisinfectionSterilizationClinical EducationVendor Credentialing
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 sterilization of Fujifilm endoscopy products
- Collaborate with headquarters, customers, third-party companies, sales, field personnel, international liaisons, and Japan-based marketing/R&D teams
- Develop 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 product labeling
- Develop policies, policy statements, and customer and sales representative notifications regarding infection control and reprocessing
- Provide education and information on infection control and reprocessing issues
- Establish educational tools and review training aids
- Assist sales management and Product Management with luminary customer development and maintenance in key U.S. target markets
- Represent the company on national committees and at meetings and seminars developing reprocessing guidelines
- Monitor and communicate new reprocessing, 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 FDA, ISO, legal, regulatory, and applicable standards requirements
- Travel 30–50% depending on business needs
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 and reprocessing knowledge of medical devices
- Background/experience working with the FDA
- Knowledge of biological evaluation of medical devices and biocompatibility
- Ability to work independently and in a close team environment
- Exceptional communication/interpersonal, analytical, and problem-solving skills
- Proficient computer skills using Word, Excel, and PowerPoint
- Effective time management skills
- High command and literacy in endoscopic application
- Strong analytical and critical thinking 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, talking, and hearing
- Ability to occasionally lift and/or move up to 30 lbs
- Specific vision abilities including close, distance, color, and depth vision, perception, and focus adjustment
- 3–5 years’ experience as an accredited microbiologist preferred
- Master’s degree preferred
- Willingness to travel 30–50% depending on business needs
- Compliance with applicable facility vendor credentialing and vaccine requirements where applicable
Benefits
Comp & perks- Dynamic, flexible environment
- Equal opportunities in hiring, promotion and advancement, compensation, benefits, and training
- Reasonable accommodation in the application, interview, testing, and selection process
- Company-required vaccination/testing and face covering policies as applicable, with legally required accommodations