Director of Endoscopy Reprocessing and Infection Control
New
Source API remote eligibility restrictions: United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 10-12 years’ experience in medical device reprocessing
Requirements
- Bachelor’s degree in biology or microbiology (Master’s preferred).
- Minimum of 10-12 years’ experience in medical device reprocessing (cleaning, disinfection, sterilization) and infection control.
- Extensive cleaning/reprocessing knowledge of medical devices.
- Background working with the FDA and knowledge of biological evaluation of medical devices (biocompatibility).
- 3-5 years’ experience as an accredited microbiologist preferred.
- Exceptional communication, interpersonal, analytical, and problem-solving skills.
- Proficiency in Word, Excel, and PowerPoint.
- Ability to travel 30-50%.
Responsibilities
- Collaborate with headquarter liaisons and teams to communicate subsidiary needs and US requirements.
- Develop and support validation programs for testing endoscope designs and reprocessing instructions.
- Partner with Japan teams to support FDA requests, 522 studies, and Human Factors Testing.
- Serve as technical writer for endoscope operation/reprocessing manuals and product labeling.
- Develop policies and notifications regarding infection control and reprocessing issues.
- Serve as a senior corporate source of education for infection control/reprocessing.
- Establish educational tools and review training aids.
- Assist sales and product management with luminary customers.
- Represent the company on national committees and industry meetings.
- Validate and expand reprocessing options with third-party AER and sterilizer OEMs.
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