Andy Lee
Manager, Manufacturing Quality Systems @Synaptive Medical
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WORK HISTORY
Manager, Manufacturing Quality Systems @Synaptive Medical
Lead and implement improvements in manufacturing quality engineering processes and tools including tool validation, process validation, supplier evaluation, incoming inspection, in-process and final testing, non-conformances and device release• Develop and maintain department KPIs• Responsible for NPI manufacturing quality planning including working with manufacturing engineering to develop IQ/OQ/PQ process validation schedule, Quality plan, PFMEA, inspection planning, to ensure QMS compliance• Assist in planning and preparation for external third party audits/inspections such as FDA inspections, ISO 13485 audits, Health Canada audits, CE Mark audits, TUV factory audits
EDUCATION
Ryerson University
Bachelor's Degree
SKILLS
ABOUT ANDY LEE
With over 10 years of experience in the medical device industry, I am a passionate and dedicated Manager of Manufacturing Quality Systems at Synaptive Medical, a leading innovator in neurosurgery. I hold two relevant certifications: ASQ Certified Quality Process Analyst (CQPA) and Certified IPC Specialist (CIS).As a manager, I lead and implement improvements in manufacturing quality engineering processes and tools, ensuring compliance to regulatory standards and customer satisfaction. I also develop and maintain department KPIs, assist in planning and preparation for external audits and inspections, and support NPI manufacturing quality planning. I have strong technical skills in biomedical engineering, as well as soft skills such as communication, problem-solving, and teamwork. I am always eager to learn new skills and technologies to enhance the quality and efficiency of our products and processes. My goal is to contribute to the advancement of medical technology and improve the lives of patients.
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