Hector Shan

Background

About Hector Shan

I am a quality-focused professional with a strong foundation in laboratory analysis, compliance, and process improvement. With experience spanning manufacturing, medical device, and clinical informatics, I bring a unique perspective that blends technical testing, regulatory standards, and data-driven decision making. At Buzzi Unicem USA, I ensure cement production meets ASTM/AASHTO and ISO 9001 standards through advanced testing (XRF, TGA, Blaine fineness) and direct collaboration with engineers to optimize raw mix and clinker quality. My prior roles at B. Braun Medical and Oak Street Health reinforced expertise in GMP, ISO 13485, HIPAA compliance, CAPA investigations, and quality documentation. I hold a Lean Six Sigma Green Belt (CSSC) and am pursuing further certifications in quality engineering and auditing. My academic background — a B.S. in Biology, Pre-Medical Studies (Cum Laude) — emphasized analytical chemistry, data interpretation, statistics, and lab sciences, skills I now apply to root cause analysis (RCA), corrective/preventive actions (CAPA), and process optimization. I am passionate about advancing into a Quality Engineer role, where I can apply my certifications, compliance knowledge, and continuous improvement mindset to reduce defects, enhance efficiency, and deliver measurable results. Specialties: Lean Six Sigma (LSSGB)| Root Cause Analysis (RCA)| Corrective & Preventive Actions (CAPA)| ISO 9001 / ISO 13485 | GMP Compliance | Statistical Process Control (SPC)| Analytical Testing | Process Improvement | Quality Assurance