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Principal Sterilization Microbiologist

Req ID:  2748

Working Location: MINNESOTA, BROOKLYN PARK; MASSACHUSETTS, WESTBOROUGH 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

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 minimise 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 Requirements

REQUIRED QUALIFICATIONS

 

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. 

 

* Some contact with customers, consultants, surgeons, product users, patients, and suppliers, including domestic and international travel.

 

PREFERRED QUALIFICATIONS

 

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.

 

* Working directly with manufacturing and research & development engineering in evaluation of prototypes for new product, modifications, and/or improvements.

 

* Working with manufacturing in implementation of new or revised products. 

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || 


Nearest Major Market: Minneapolis

Job Segment: Engineer, QA, Quality Assurance, Biomedical Engineering, R&D Engineer, Engineering, Quality, Technology

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