Microbiology & Sterility Assurance Leader

Requisition

Job Title:
Microbiology & Sterility Assurance Leader

Job Country:
United States (US)

Here at Avanos Medical, we passionately believe in three things:

• Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
• Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
• Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries.

Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit

Responsible for supporting the development, implementation, maintenance, and continuous improvement of Microbiology and Sterility Assurance Operations in accordance with established procedures, corporate policies, and applicable regulatory standards.

The incumbent reports to Sterility Assurance Quality Operations team in Alpharetta and will work closely with other departments to:

• Support the implementation of Global Microbiology and Sterility Assurance program at the Avanos manufacturing sites.
• Assist Sterility Assurance activities to execute validation activities for terminal sterilization methods (ethylene oxide, gamma irradiation) required to support medical product manufacturing.
• Provide microbiology and sterilization sciences leadership and validation subject matter expertise in support of product design and/or material changes.
• Establish a periodic and formal contact with the manufacturing areas, providing support to evaluate Microbiology and Sterility results.
• Work within cross‑functional teams to provide technical support in regard to product sterilization and environmental monitoring requirements.
• Ensure compliance to quality system and sterilization standards requirements supporting global activities for microbiology and sterilization requirements according to ISO 13485, ISO 17025, ISO 14644, ISO 11135, ISO 11137 and GLP environments.

• Support the development and maintenance of global microbiology and sterilization procedures, work instructions, and quality documentation to ensure compliance with internal and regulatory requirements.
• Work with contract sterilizers and contract laboratories to support execution of sterilization validation and microbiology testing.
• Perform investigations of non‑conformities found in processes concerning microbiology and sterilization, including review of Bioburden and LAL Endotoxin test results.
• Actively participate in and/or facilitate the development of sterility assurance deliverables required for product changes.
• Contribute to continuous improvement initiatives aimed at strengthening microbiology, laboratory, sterilization, and environmental performance and compliance.
• Assist with the qualification, calibration, and maintenance of laboratory instrumentation and equipment.
• Ensure all microbiology and sterilization activities comply with applicable standards (e.g., ISO, FDA, GMP/GLP, internal QMS).
• Assist in periodic review and revision of microbiology and sterilization procedures to maintain accuracy and alignment with current practices.
• Conduct training for microbiology and sterilization personnel on procedures, safety practices, and quality expectations.
• To support the evaluation of the effectiveness of the sterilization and cleanliness programs in the manufacturing areas through particle and microorganism monitoring and bioburden on the finished product.
• Control, verification and maintenance of the fulfillment program of the Bioburden and LAL Endotoxin program for EO/Gamma Sterilization process.
• Support microbiology and sterilization validations and maintain the Sterilization, Environmental and Lab Master Validation Plan.
• Responsible to complete EO and Gamma sterilization assessments.
• Participate in the evaluation and qualification of controlled environments (e.g., clean rooms, laminar flow hoods, biological safety cabinets, incubators).
• Monitor compliance with microbiology and sterilization control policies and elevate abnormalities, excursions, or trends as appropriate.
• Support readiness activities and documentation for regulatory inspections and audits.
• Support with execution of activities for sterilization assessment for new…