Assurance specialist

Sr. Sterility Assurance Specialist (Equipment SME) (

Job Number : QUA0101W2 )

QUA0101W2 )

Primary Location

US-IL-Northfield

Description

JOB SUMMARY :

Lead advanced, technical sterilization support for sterilization related projects among various Medline product divisions, sterilization facilities, and contract laboratories to maintain compliance to regulations and industry standards ( 21 CFR Part 820, ISO11135, ISO11137, ISO13485 etc.

Apply engineering, microbiology and chemistry principles to develop, support and troubleshoot sterilization processes and challenges across multiple modalities.

MAJOR RESPONSIBILITIES :

• Provide expert technical expertise for sterilization related projects for all modalities used by the company including ethylene oxide, radiation, and steam.
• Interact directly with FDA, notified bodies, and customers. Develop responses to sterilization related requests and audit findings.
• Provide technical support as needed during audits of Medline facilities, sterile vendors, sterilization facilities, and contract laboratories to make sure they comply with regulatory requirements.
• Participate in technical committees such as AAMI sterilization standards development. Active participation includes reviewing proposed standards and submitting comments as well as attending periodic meetings.
• Monitor sterilization industry practices against internal processes and create or update procedures to maintain industry and regulatory compliance.
• Develop sterilization training materials. Conduct training for the sterilization department, other quality team members, and divisional personnel.
• Develop and review statistical analysis data and make recommendations for improvement as well as establish implementation plans.
• Meet with divisional personnel to provide technical assistance and make decisions related to ethylene oxide, steam, and radiation sterilization processes.

Facilitate completion of sterilization activities on time as committed.

Participate and support projects for international sterilization teams. Onsite participation may be required.

Qualifications

Education

Bachelor’s Degree with a scientific or engineering background.

Certification / Licensure

CISS (Certified Industrial Sterilization Specialist).

Work Experience

• At least 4 years of direct experience working in the industrial sterilization of healthcare products. This must include EO cycle development and validation, radiation dose setting, and moist heat experience.
• Experience supporting sterilization topics to regulators ( FDA, ISO NB) during audits and inspections.

Knowledge / Skills / Abilities

• Strong understanding of ISO 11135, ISO 11137, and ISO 17665.
• Strong understanding of chemistry principles related to EO / ECH residuals.
• Ability to work safely in environments where hazardous chemicals may be encountered under corporate safety rules and requirements.
• Position requires travel up to 20% of the time for business purposes (within state and out-of-state).

PREFERRED JOB REQUIREMENTS

• Member of AAMI sterilization working groups / committees.

Last updated : 2024-05-21