ALLESET, Inc.
Purpose:
The ETO Facility QA position is responsible for supporting the quality assurance processes and ensuring the proper functioning of the ETO sterilization facility. This role focuses on maintaining compliance with regulatory standards, monitoring sterilization cycles, ensuring product quality, and managing documentation. The position works closely with production, engineering, and regulatory teams to ensure a seamless and compliant sterilization process.
Responsibilities:
Quality System Management:
The ETO Facility QA position is responsible for supporting the quality assurance processes and ensuring the proper functioning of the ETO sterilization facility. This role focuses on maintaining compliance with regulatory standards, monitoring sterilization cycles, ensuring product quality, and managing documentation. The position works closely with production, engineering, and regulatory teams to ensure a seamless and compliant sterilization process.
Responsibilities:
Quality System Management:
- Assist in maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485, FDA, and other regulatory requirements.
- Ensure compliance with company SOPs and regulatory standards, including GMP (Good Manufacturing Practices) related to ETO sterilization.
- Monitor ETO sterilization processes, ensuring adherence to validated protocols and specifications.
- Review sterilization cycle data and documentation for accuracy and completeness.
- Perform the BI incubation and record the result in DHR records.
- Communicate with customers for sterilization validation activities.
- Support validation and revalidation efforts for sterilization processes
- Ensure accurate and timely documentation of all sterilization activities, including sterilization DHR records, validation records, and calibration logs.
- Maintain device history records (DHR) and ensure they are complete and properly archived for regulatory inspections and audits, include scan and storage.
- Assist in investigating and documenting non-conformances, sterilization failures, and deviations.
- Support Corrective and Preventive Action (CAPA) processes to ensure non-conformances are addressed, root causes are identified, and preventive measures are implemented.
- Participate in internal and external audits to ensure compliance with regulatory standards (e.g., FDA, ISO 13485).
- Assist in preparing audit documentation and responding to audit findings.
- Review sterilization DHR records for completeness and accuracy before product release.
- Ensure that products meet quality standards and sterilization requirements before distribution.
- Schedule the equipment calibration and verify the calibration records to ensure compliance.
- Work with the engineering and maintenance teams to ensure all equipment operates within defined specifications and to address any equipment-related quality concerns.
- Assist in training employees on quality processes, regulatory requirements, and best practices in ETO sterilization.
- Support continuous improvement initiatives aimed at enhancing process efficiency, reducing non-conformances, and improving overall quality.
- Verify WH received load and assign ETO internal load #.
- Verify WH received EO gas and conduct verification.
- Monitoring facility environment as needed.
- Bachelor's degree in a relevant field (e.g., engineering, chemistry, biology) or equivalent experience.
- Proven experience in quality control, quality assurance, or a related field.
- Experience with ETO sterilization processes and associated quality standards.
- Familiarity with regulatory requirements (OSHA, FDA, EPA, ISO standards) related to sterilization.
- Knowledge of QMS, Good Manufacturing Practices (GMP), and CAPA systems.
- Excellent problem-solving skills.
- Strong communication and interpersonal skills.
- Attention to detail and a commitment to accuracy.
- Proficiency in using quality control tools and software.
- Prior experience in healthcare is preferred.
- This position may require long periods of sitting or standing.
- Minimal lifting required.
- Use of fingers, hands, or feel objects.
- Climb stairs.
- Stand, sit, stoop, kneel, and crouch.
- Close vision and depth perception.
- Willingness to travel to supplier locations for audits and assessments.
- Must be comfortable working in a controlled industrial environment, adhering to strict safety protocols.
- Requires compliance with PPE standards for ETO sterilization facilities.