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Key Responsibilities:
- Collaborate with Fujifilm Tokyo to align reprocessing recommendations with US market needs and FDA requirements.
- Oversee validation testing of endoscope designs and reprocessing instructions with external labs.
- Develop and review product labeling, operation manuals, and educational tools for reprocessing.
Qualifications:
- Bachelor's degree in biology or microbiology required; Master's preferred.
- 10-12 years of experience in medical device reprocessing and infection control.
- 3-5 years as an accredited microbiologist preferred.
Skills and Experience:
- Extensive knowledge of cleaning, disinfection, and sterilization of flexible endoscopes.
- Proven track record working with FDA and biocompatibility evaluation.
- Strong analytical, communication, and team leadership abilities.
Work Environment:
- Fully remote role with 30-50% travel as needed.
- Physical demands include standing, walking, and occasional lifting up to 30 lbs.
- Compliance with COVID-19 vaccination requirements per facility mandates.
FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, endoscopic and surgical imaging, and in-vitro diagnostics. Fujifilm globally employs over 70,000 people and is guided by a purpose of giving the world more smiles.