Director of Endoscopy Reprocessing and Infection Control

Duties and Responsibilities

• Collaborate with headquarter liaisons and teams to effectively communicate subsidiary needs and US requirements for reprocessing and infection control issues.
• Develop or/and support validation program for testing of endoscope designs and reprocessing instructions, working with Fujifilm Tokyo and independent microbiology laboratories as necessary.
• Partner with Fujifilm Japan to support FDA requests and requirements including 522 Postmarket Surveillance Studies and Human Factors Testing of Fujifilm products, as necessary.
• Serve as technical writer/reviewer to develop and/or revise endoscope operation and reprocessing manuals based upon latest industry guidelines and review/improve product labeling for accuracy, consistency and ease of understanding.
• Review operation manuals for any comments/instructions related to reprocessing.
• Develop policies, policy statements, customer, and sales rep notifications regarding infection control/reprocessing issues.
• Serve as a senior corporate source of education & information for infection control/reprocessing issues.
• Establish educational tools and review training aids (such as QRGs, slide presentations) on reprocessing and infection control practices.
• Aid sales management and Product Management with development and maintenance of luminary customers in key target markets in US.
• Represent the company on national committees and at meetings/seminars developing reprocessing guidelines.
• Keep Fujifilm Tokyo well informed of any new reprocessing/infection control trends and/or guidelines.
• Have adaptable learning skills and an established track record of being a subject matter expert on reprocessing and infection control matters.
• Work with third-party companies including AER and sterilizer OEMs to validate and expand reprocessing options for Fujifilm endoscopes.
• Oversee/manage HCUS Clinical Education Manager responsible for reprocessing training of HCUS personnel and customer in-services.
• Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO standard requirements and all other applicable laws, regulations, and standards.

Qualifications

• Bachelor’s degree in biology or microbiology is required. A Master’s degree preferred.
• Minimum of 10-12 years’ experience in medical device reprocessing, (cleaning, disinfection and sterilization) validation studies and infection control best practices including a strong background of flexible endoscopes.
• 3-5 years’ experience as an accredited microbiologist is preferred.
• Extensive cleaning/reprocessing knowledge of medical devices is required.
• Background/experience working with the FDA and knowledge of the biological evaluation of medical devices (Biocompatibility).
• Highly focused and results-oriented; able to identify goals and priorities and resolve issues in initial stages.
• Demonstrated ability to work independently and in a close team environment, self-starter who can motivate others.
• Possess exceptional communication/interpersonal, analytical, and problem-solving skills.
• Work remotely
• Proficient computer skills using Word, Excel, PowerPoint.
• Effective Time Management skills.
• 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 all internal and external customers.
• Physical requirements: The position requires the ability to perform the following physical demands and/or have the listed capabilities: Frequently required to stand; walk; use hands to finger, handle or feel objects, ability to use a keyboard, reach with hands and arms; balance; stoop, kneel, crouch; and talk or hear. Occasionally lift and/or move up to 30 lbs.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
• Travel: 30-50% depending upon business needs.