# ALBERTO SANCHEZ, M.S., CMQ OE, CQE, CSSGB, CQA, CPGP > Accomplished Quality Assurance Director with strengths in Medical Device Quality Systems, Design Assurance, Lean Six Sigma, Audit management, Risk Management per ISO 14971, and SW for Medical Devices per IEC62304. Location: San Francisco Bay Area, United States Profile: https://flows.cv/albertosanchezmscmqoecqecssgbc Experienced and hands-on Quality and Technical leader with deep subject-matter expertise in Quality Systems, Quality Engineering, and Product Development across Class II & III Medical Devices. Proven success supporting instrumentation for diagnostics, vascular, urology, and surgical applications, as well as high-volume disposable manufacturing and telecommunication fiber-optic systems. Core Competencies: • Domestic & International Regulatory Compliance (FDA, EU MDR/IVDR, ISO) • Audit Readiness & Support (Front/Back Room for Internal, Notified Body, and Regulatory Inspections) • Design Assurance & Risk Management • Sterilization (ETO, H₂O₂), Biocompatibility, and Stability Testing • Verification/Validation & Test Method Development • DHF, Design Dossier & Technical File Management • Supplier Quality & Supply Chain Audits • Process Development, Equipment Qualification, and Process Control • Laser/Optics Subsystems & Electrical/Laser Safety • REACH/RoHS Compliance & Environmental Regulations • Packaging Engineering & Transit Studies • Technical Writing, Training, and Cross-functional Collaboration ## Work Experience ### Sr. Manager, New Product Development and Sustaining Quality @ Waters Corporation Jan 2026 – Present | United States Responsible for New Product Development and Sustaining Quality for Instruments (Flow Cytometry/Cell Sorter/Sample Preparation), Software, Informatics, Assay/Reagents ### Sr. Manager, Design Assurance @ Abbott Jan 2017 – Jan 2026 | Santa Clara, CA Managed five direct reports and contributed to the Design Quality team for Class 2 Alinity h-series blood analyzer and CELL-DYN platform instruments. Collaborated with cross-functional teams, including Program Management, Software/System/Hardware Engineering, Reagents/Consumables Development, Regulatory, Commercial Marketing, Medical Affairs, Clinical, Product Quality, and On-Market Engineering. Handled design planning, design inputs/outputs, risk management, device master record, design transfer, and product launch activities. Supported audits, reported design quality metrics, oversaw HW/SW design changes, and provided quality support for design plan and DHF deliverables. Implemented design control training and led the Alinity h system project for US 510(k) submission. Received Core Diagnostics President’s Award in 2023. Skills Highlighted: Team Management Cross-functional Collaboration Design Planning Risk Management Audit Support Quality Metrics Reporting HW/SW Design Changes Design Control Training Project Leadership Award Recognition ### Quality Manager @ Thoratec, now a part of St. Jude Medical Jan 2014 – Jan 2016 | Sunnyvale, CA Managed seven direct reports and four temp personnel for quality systems, design assurance, and quality engineering activities for Class 3 disposable catheter and Class 2 controller devices. Handled CAPA, complaints management, and FDA submission preparation activities. Trained site personnel for audits, received EN ISO 13485 QMS and MDD (CE) certification, and St. Jude Pinnacle Award. Developed quality system, wrote procedures, and supported FDA IDE and 510K submissions. Acted as subject matter expert for design assurance, risk management, biocompatibility, and global compliance. Prepared master quality plan for site decommissioning and product transfer. Skills Highlighted: Team Management Quality Systems Design Assurance Regulatory Compliance Audit Training Award Recognition ### Director, Quality Engineering @ Solta Medical, Inc. Jan 2012 – Jan 2014 | Hayward, CA Managed DHFs, risk management files, and post-market surveillance activities, including technical files, quality planning, and annual product review. Supported global compliance activities, including complaint investigations, product list and application updates, design change notifications, annual CDRH laser reports, electrical safety testing, supplier audits, and compliance. Supported internal audits and front-room representative for notified body / FDA audits. Acted as project manager for ROHS implementation for RF, laser, IPL, and ultrasound energy product families consisting of 5K components. Provided QE support for multiple product families (design changes for ~20 projects) ### Director, Quality Assurance @ Intrapace Jan 2011 – Jan 2012 | Mountain View, CA Oversight of document control, QA / QC, supplier quality, design quality, and QMS for Class 3 obesity management device. Oversaw calibration and equipment maintenance processes, CAPA, document control / records management, quality engineering, and EH&S. Revised and released product returns SOPs, including explant return kit and servicing lifecycle SOP. Initiated Lunch-and-Learn quality training program for CAPA, compliance, risk management, and process validation. Managed 2012 BSI microbiology audit with zero non-conformances. ### Director / Sr. Manager, Quality @ American Medical Systems Jan 2003 – Jan 2011 | San Jose, CA Management Representative and Facilitator for Notified Body (BSI), FDA, and PMDA (Japan) audits, front-room audit manager. Oversight of Calibration and equipment maintenance processes, CAPA, Complaints, Document Control and Records Management, Electrical compliance, Quality Engineering, Quality Management System, Receiving inspection, Training compliance. Technical Subject Matter Expert and Project Support for Quality Engineering, Document Control, Quality Assurance / Control, Measurement Systems and Maintenance, Ethylene Oxide Sterilization, Controlled Environment Commissioning, Materials Biocompatibility, Packaging, Risk Management, Verification and Validation, Domestic / International Compliance, Device Failure Analysis, Process Development and Control, Corrective / Preventive Action, External / Internal Audit Management, Supplier Quality. ### Quality Assurance Manager @ American Medical Systems Jan 2003 – Jan 2006 | San Jose, CA Management oversight of Quality Engineering, Final Product Release, Supplier Quality, Receiving Inspection, Material Review Board, and Equipment Calibration for Laser and Device Manufacturing. Prepared test procedures for optical component testing, audited optics suppliers, and coordinated procurement and setup of cleanroom equipment for optics and critical component handling. Work performed under Laserscope before AMS acquisition. ### STAFF MATERIALS ENGINEER @ JDS UNIPHASE / E-TEK DYNAMICS Jan 1999 – Jan 2003 | San Jose, CA Developed Specifications for Optical Components used in Optical Networks, Global Supply Chain team member performing supplier audits, performed SPC analysis and identified and implemented changes for yield improvement, prepared Quality plans and component specifications / drawings. Work performed under E-TEK Dynamics, acquired by JDS Uniphase. ### Senior Mfg. Engineer, Laser Systems @ Laserscope Jan 1994 – Jan 1999 | San Jose, CA Manufacturing Engineering support to Operations, Quality Systems, and R&D Engineering. Manufacturing technical support for Solid-state and Dye laser systems. Ownership of electrical, mechanical, and optical component and assemblies used in medical laser systems. Product Development team member, developed and released novel office-based lasers for Aesthetic and Surgical market. Prepared detailed Manufacturing Plans as part of New Product development teams. Wrote assembly and test procedures, structured bill of materials, released documentation, and trained Production personnel in testing, assembly, troubleshooting, equipment usage, methods / processes, and procedures. ### Optical Manufacturing Engineer @ Continuum Electro-Optics Jan 1991 – Jan 1994 | Santa Clara, CA Optical engineering support for manufacturing and custom-built high-power pulsed laser system optical components: reflective and transmissive optics, solid-state laser media (Nd:YAG, Glass, and Ti:Sapphire rods), non-linear crystals (BBO, KTP and KD*P), Pockels cells, polarizers, and Faraday rotators. New product development optical engineering support for diode-pumped Nd:YAG laser and Optical Parametric Oscillator (OPO) products. ### Thin-film engineer @ Spectra-Physics Jan 1987 – Jan 1991 | Mountain View, CA Designed optical coatings, defined coating process parameters, and performed optical testing of high-power laser damage threshold optical coatings. Developed optical test plans and inspection procedures for optical components. Performed optical test metrology, which included scratch-dig integration, spectrophotometry, interferometry, laser photometry, scatterometry, ellipsometry, and coating absorption measurements ## Education ### M.S. in Physics San José State University ## Contact & Social - LinkedIn: https://linkedin.com/in/alberto-sanchez-quality - Portfolio: http://www.ieee.org - Portfolio: http://www.asq.org - Portfolio: http://nscaa.com --- Source: https://flows.cv/albertosanchezmscmqoecqecssgbc JSON Resume: https://flows.cv/albertosanchezmscmqoecqecssgbc/resume.json Last updated: 2026-04-13