Quality Assurance Associate / Sterilization Technician
Responsible for incoming and in-process quality control to ensure compliance to product specifications. Ability to utilize various inspection tools, such as: calipers, micrometers, optical comparator, gauge pins, blocks, square, sine bar, and height gauges.
- Develop test methods and sampling plans to meet business requirements and support projects
- Provide technical support to new product development through execution of design validation and verification protocols.
- Ensure appropriate revision of documents for compliance and improvement utilizing document change requests.
- Identify, segregate, document, and disposition nonconforming product.
- Working knowledge of GMPs, GDPs, FDA QSR, ISO 13485, and ANSI/ASQ sampling plans.
- Sterilization technician for in-house EO sterilization process compliant to ISO 11135. Maintained sterilization run traceability, BI test results, sterilizer operation, validation load building, PCD preparation and placement, and assisted with transfer of sterilization process to contract sterilizer. Responsible for review and release of contract sterilization documentation.
- Promoted from manufacturing associate to sterilization technician and finally to QA Associate.