Director of Endoscopy Reprocessing – Infection Control

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the reprocessing and infection control initiatives related to the endoscopic product line.

• Act as the primary resource and subject matter expert for the cleaning, high-level disinfection, and sterilization of Fujifilm endoscopy products.

• Collaborate with liaisons from headquarters, customers, third-party vendors, sales teams, field personnel, international contacts, marketing, and R&D teams in Japan.

• Create and/or assist in the development of validation programs for endoscope designs and reprocessing guidelines.

• Support FDA inquiries and requirements, including 522 Postmarket Surveillance Studies and Human Factors Testing.

• Draft and update endoscope operation and reprocessing manuals while enhancing product labeling.

• Formulate policies, policy statements, and notifications for customers and sales representatives regarding infection control and reprocessing.

• Develop educational resources and review training materials focused on reprocessing and infection control practices.

• Assist in the growth and maintenance of luminary customers in key U.S. target markets.

• Represent the company in national committees and at meetings and seminars focused on developing reprocessing guidelines.

• Stay updated and communicate new trends and guidelines in reprocessing and infection control to Fujifilm Tokyo.

• Collaborate with AER and sterilizer OEMs to validate and broaden reprocessing options.

• Supervise the HCUS Clinical Education Manager responsible for reprocessing training.

• Adhere to U.S. FDA medical device regulations, ISO standards, and relevant laws and regulations.

⛳️ Requirements

• A Bachelor’s degree in biology or microbiology is mandatory.

• A minimum of 10-12 years of experience in medical device reprocessing, validation studies, and infection control best practices is required.

• A solid background in flexible endoscopes is essential.

• Extensive knowledge of cleaning and reprocessing medical devices is necessary.

• Experience working with the FDA is required.

• Knowledge of biological evaluation for medical devices (biocompatibility) is crucial.

• Preferred experience of 3-5 years as an accredited microbiologist.

• Proficient in computer applications such as Word, Excel, and PowerPoint.

• High proficiency and literacy in endoscopic applications.

• Strong analytical and critical thinking capabilities.

• Excellent communication, interpersonal, analytical, and problem-solving skills.

• Capability to work independently and collaboratively within a team environment.

• Effective time management skills.

• Ability to read, analyze, and interpret critical job-related documents.

• Proficient in presenting and effectively communicating with both internal and external customers.

• Capable of meeting physical demands including standing, walking, keyboarding, reaching, balancing, stooping, kneeling, crouching, and auditory communication.

• Ability to occasionally lift and/or move up to 30 lbs.

• Ability to meet necessary vision requirements, including close, distance, color, and depth perception, along with focus adjustments.

• Willingness to travel 30-50% as business needs dictate.

• Ability to comply with facility vendor credentialing requirements, including applicable vaccine mandates.

• Willingness to undergo periodic COVID-19 testing and wear a face covering indoors as required, subject to legally mandated accommodations.

🏝️ Benefits

• Flexible work environment.

• Remote work options available.

• Commitment to equal opportunities in hiring, promotions, compensation, benefits, and training.

• Reasonable accommodations provided during the application and employee selection processes.

• COVID-19 vaccination is encouraged.

• Periodic COVID-19 testing and indoor face coverings are required as necessary, subject to legally mandated accommodations.