Winnie P. Email & Phone Number

El Segundo, California, United States

• Managed reprocessing validations for manual cleaning, high-level disinfection, and sterilization of various reusable diagnostic medical devices to secure FDA clearance and develop Instructions for Use (IFU).• Served as a Subject Matter Expert (SME) in the reprocessing of medical devices, ensuring compliance with ANSI/AAMI Standards and FDA regulations.• Collaborated with cross-functional teams throughout the entire lifecycle of new product development, contributing to successful Premarket FDA submissions.• Supported Regulatory Affairs in obtaining seven (7) FDA Premarket Notifications (510(k)) clearances across diverse classes of reusable medical devices during a five-year tenure.• Developed protocols and coordinated cleaning validations for various classes of reusable medical devices with external laboratories.• Designed protocols and managed high-level disinfection studies for camera heads in collaboration with external laboratories.• Initiated sterilization protocols using STERRAD, V-PRO, and steam sterilization modalities for reusable medical devices, ensuring compatibility with appropriate sterilization cases and trays.• Conducted regular assessments to evaluate product adoption feasibility on legacy products, focusing on manual cleaning, high-level disinfection, and both high and low-temperature sterilization methods.

Irvine, California, United States

• Utilized wet chemistry techniques to analyze various Intravenous (IV) solutions, ensuring accuracy and compliance with regulatory requirements.• Conducted qualitative and quantitative assessments of amino acid products using a variety of chemical assays to maintain product quality and consistency.• Led departmental laboratory investigations to resolve Out-of-Specification (OOS) conditions, ensuring compliance with regulatory standards.• Certified as a Train-the-Trainer to educate new and existing employees on updated protocols and procedures, fostering a culture of continuous improvement.• Implemented an efficient log-in system for incoming raw materials, in-process samples, and finished samples to enhance process visibility and facilitate process improvements.• Collaborated with vendors and Metrology for routine validation and calibration of various laboratory instruments, ensuring accuracy and reliability of test results.• Scheduled and executed equipment qualification activities (IQ/OQ/PQ) to ensure compliance with regulatory requirements and operational efficiency.

Irvine, California, United States

• Managed in-process inspection and conducted production monitoring to detect and resolve discrepancies, ensuring adherence to quality standards.• Conducted audits of in-process activities to assess compliance with standard operating procedures and regulatory requirements.• Identified and mitigate discrepancies in preliminary product dispositions to maintain product quality and safety.• Performed environmental monitoring of cleanrooms (ISO Class 5, 7, and 8), including collection and analysis of airborne particles, work surfaces, and water samples to maintain cleanliness and compliance.• Reviewed Production Batch Records daily to ensure accuracy, completeness, and compliance with established protocols and regulatory standards.

Irvine, California, United States

• Cultured, inoculated, and harvested Geobacillus Stearothermophilus organisms for testing biological indicators in Sterrad Cyclesure 24, ensuring the efficacy of sterilization processes.• Characterized product purity using titrations, plate counting, pH analysis, and sterility testing to maintain quality and compliance with regulatory standards.• Conducted laboratory testing utilizing aseptic techniques to ensure accurate and reliable test results.• Inspected and reviewed documents, worksheets, and document history records to verify accuracy, completeness, and compliance with protocols.• Formulated solutions from raw materials, maintaining precise measurements and documentation to support laboratory operations and experimental procedures. • Managed SDS sheets for incoming raw materials.