Sinna Sim Email & Phone Number

Quality professional with 6+ years of industry experience. Significant quality engineering, complaint investigation and failure analysis experience. Cross-functions effectively with multiple departments and levels of the organization. Supported various internal and external auditing activities. Maintain documentation and processes to FDA requirements, ISO standards and various regulating bodies. Evaluate risk and ensure product safety and efficacy impact are appropriately addressed. Lead investigations for control of product and process non-conformances. Support production activities related to root cause determination and CAPA resolution. Address indications and prevention of potential non-conformances. Sustain and improve complaints process for resolution of MDRs and manufacturing related occurrences. Supported substantial projects to implement process improvement and system changes for multiple products. Ensure manufacturing methods and practices are compliant with industry requirements and business objectives. Supported design transfers, validation, and remediation activities. Advanced protocol and report writing skills, including equipment qualifications (IQ/OQ), process performance qualifications (PPQ), measurement systems analysis (MSA), test method validation, statistical/data analysis and risk management. Proficient with the following data processing systems – SAP ERP, Minitab, Windchill, InfoMed, and EPIQ systems.

Listed skills include Fda, Quality System, Medical Devices, Capa, and 22 others.