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Alexander P.
Quality Audit Specialist @Synthego
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WORK HISTORY
Quality Audit Specialist @Synthego
EDUCATION
San José State University
Bachelor of Science - BS, Industrial and Systems Engineering
ABOUT ALEXANDER P.
I’m a Quality Audit Specialist focused on building compliant, audit-ready systems that meet FDA and ISO standards in the medical device and biotechnology industries. My work centers on supplier qualification, CAPA effectiveness, risk management, and cross-functional quality initiatives that support product integrity and regulatory readiness- Lead internal and external audits, supplier assessments, and qualification activities- Experienced in GMP compliance, change control, and process validation- Skilled in FDA, ISO 9001/13485, and risk assessment methodologies (FMEA, SPC)- Proven record of improving quality systems and audit outcomes through data-driven decision makingI’m passionate about creating quality systems that not only meet regulatory expectations but also drive operational excellence.
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