Principal Sterilization Microbiologist - Remote

Working Location: NATIONWIDE; MINNESOTA, BROOKLYN PARK 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

 

Job Description

The jobholder is responsible for providing Sterilization Microbiological expertise to the Olympus Surgical Technologies America group and ensuring that the Operational activities in regards to biocompatibility, cleaning, disinfection, and sterilization are in compliance with internal and external requirements and regulations.

Job Duties

• Author Cleaning, Disinfection, and Sterilization validations for new or existing products.
• Participate in vendor evaluation, verifying the controls for patient contact and controlled-environment entry parts to minimize the risk to the manufacturing operation and patient through the use of contaminated supplies.
• Assist with the initial review and routine evaluation of Cleaning, Disinfection, and/or Sterilization contractors.
• Assist with initial review and routine evaluation of laboratories conducting sterilization, environmental or microbiological services, to ensure that laboratories provide reliable results and meet regulatory and internal expectations.
• Perform audits of Olympus OSTA sites to ensure that best practice is being maintained in controlled areas and establish
• that pertinent activities are effectively implemented.
• Provide Mentoring and training to Sterilization Microbiologists II.
• Ensure products are designed and evaluated for cleanliness, disinfection and sterilization.
• Lead and/or assist in the investigation of Cleaning and/or Sterilization related complaints.
• All Other Essential Duties as directed.

Job Qualifications

Required:

• Bachelor's Degree in Science/Engineering/Biomedical required. MS or higher degree in microbiology preferred.
• Minimum of 10 years of experience in Medical Device Cleaning, Disinfection, and/or Sterilization within an FDA/ISO regulated medical device environment.
• Knowledge of hospital infection control practices, including cleaning, high level disinfection and sterilization procedures.
• Knowledge of biological safety requirements.
• Past experience or previous input into product design preferred for cleanliness, disinfection and sterilization.
• Good communication skills and writing skills.
• Familiarity with pertinent FDA,EUMDR, AAMI, OSHA and ASTM regulations and guidelines.
• Internal: Must interact to some degree with almost every department in the company. Most often interacts with marketing, quality assurance, research & development, regulatory, and manufacturing.
• External: Some contact with customers, consultants, surgeons, product users, patients, and suppliers, including domestic and international travel.
• For Organization Influence: Work directly with manufacturing and research & development engineering in evaluation of prototype for new product, modifications, and/or improvements. Work with manufacturing in implementation of new or revised products.

Why join Olympus?

 

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

 

Equitable Offerings you can count on: