Jobs and Careers

Senior Manager - Microbiology and Sterilization

Brooklyn Park, United Statesfull_timeVerifiedPosted 15 Nov 2023

About the role

Working Location: MINNESOTA, BROOKLYN PARK

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Senior Manager Sterilization and Microbiology will provide leadership and subject matter expertise in sterilization, microbiology, cleaning, and disinfection to cross-functional teams in support of new product development and sustaining engineering and will be accountable for meeting department and company goals and objectives.

This position will be responsible for managing the Sterility Assurance team for the Americas and will ensure compliance with internal and external requirements and regulations related to sterility assurance.

Job Duties

Executes vision and strategy for the Microbiology and Sterilization organization for the Americas.
Mentors and leads the Microbiology and Sterilization staff supporting new product development and sustaining engineering projects.
Manages sterilization activities for the different sites across the US.
Ensures the US team is supported to be able to execute against project timelines and the overall department/company goals and objectives.
Interface across Olympus business units as a microbiology and sterilization subject matter expert as a coach and mentor across multiple functions such as Quality and R&D to build and develop skills and competencies of others.
Assist with the initial review and routine evaluation of Cleaning, Disinfection, and/or Sterilization contractors.
Responsible to ensure requirements of the Regulatory requirements for microbiology and sterilization are applied and adhered to for the validation of new and existing products.
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.
Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) as the microbiology and sterilization subject matter expert.
Other responsibilities as assigned by Quality / Microbiology Management – such as microbiology and sterilization related NC’s, CAPA’s, Internal / External Observations. Service as Subject Matter Expert for Global Microbiology / Sterilization initiatives.

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.
A minimum of 5 years of leadership/supervision experience in microbiology and/or sterilization.
Strong working knowledge of microbiology and sterilization requirements for medical devices.
Strong working knowledge of hospital infection control practices, including cleaning, high level disinfection and sterilization requirements.
Strong knowledge of FDA, EUMDR, AAMI, OSHA and ASTM regulations and guidelines.
Strong collaboration and influencing skills and the ability to work across functions
Proven track record as a people leader and change agent
Must be a change agent, highly and effectively organized, be a flexible self‑starter, team-oriented and excellent at prioritization and multitasking
Up to 15% domestic and / or international travel