Hector Miranda

About Hector Miranda

Senior Engineering professional with extensive experience in the research and development of advanced product/processes and Quality Engineering in the Medical Devices industry. Utilizes strong background in Quality/Manufacturing/Industrial Engineering and Material Science to solve product implementation and manufacturing issues. Investigates and determines root cause failures and develops quality plans for technical projects with cross-functional teams. Effectively works with Suppliers, Sales/Marketing to ensure customer and regulatory requirements are met. Strong analytical skills and recognized as the person who can solve the difficult technical problems. Involved in resolving production issues with Manufacturing and Suppliers (i.e, equipment, processes, materials, validations, statistical analysis, etc.)• Medical Device Manufacturing• Quality Assurance Engineering• Experienced and knowledge of Quality System Regulations FDA 21 CFR Part 820, ISO9001, ISO13485, ISO14971 and Environmental/Trade Compliance requirements. • Design Quality Engineering (Stage/Gate)• Risk Management• Process/Manufacturing Engineering• Supplier Quality Engineering• Supplier Selection, Approval and Maintenance of ALS• Quality CAPAs/SCARs• Project Management• Strong analytical skills and Root Cause Failure Analysis • Material Selection and Testing• Bilingual (Spanish)TECHNICAL SKILLS:Materials: MEDICAL DEVICES, PV/Solar Products, MLM (Multi-Layer Materials), Thick Film, LTCC Systems, Dielectrics, Semiconductors, Ceramics for electronic industryAnalytical Techniques: SEM/EDS Microanalysis, X-ray Powder Diffraction, FTIR, C-SAM,SA, PSD, TMA, TGA/LETGA, DSC, Curve Tracer, X-ray imaging, Thermal emission, etc. Failure analysis of various electronic devices and components. Screen Printing Technologies: Baccini, Microtek, Ekra, AMI. Electrical testing: Solar (IV Tester, Corescan, Suns-voc), MLM (Cap bridges, DF, IR, TVC, BDV). GD & T. Computer: Microsoft Office, SAP/ERP, statistical software (JMP, Minitab).Methodologies: ISO9001 methods and procedures, ISO13485, ISO14971, ISO19227 and Environmental/Trade Compliance Requirements, FMEA, SPC, DOE, CAPA, SCAR, MRB, 8D, 5S, ECR, Total Quality Management, Lean Manufacturing, Six Sigma, 5S.), CATSWeb, Agile QMS.

Experience

1. Senior Quality Assurance Engineer - Design Controls and Transfer

   QuidelOrtho

   Jan 2022 — Present · San Diego County, CA, US

   Medical Devices - Development and manufacturing of diagnostic testing technologies and solutions.• Responsible for supporting new product design and development activities utilizing internal and external quality industry standards. • Technical support to Instruments and Assays related projects for Point of Care (PoC) and Molecular (PCR) diagnostics testing platforms.• Maintain project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process• Interacts in cross functional teams with R&D, Engineering, Quality, Suppliers, Software, Operations and Regulatory on design and development deliverables. • Provides updates to Management and to Project Teams, when participating in cross-functional teams. Interacts with Supplier Quality Engineers, Process Engineers and Manufacturing Quality Engineers to collaborate on quality concepts and product transitions.• Make sure quality procedures are properly followed like Design Controls, Engineering Change Orders (ECOs), Risk Management and Risks Assessments, Supplier Change Notifications (SCNs), FMEAs.

Education

• Universidad de Lima

  Bachelor of Science - BS, Industrial Engineering

Skills

• Six Sigma
• 5s
• Root Cause Analysis
• Manufacturing Operations Management
• Fmea
• Cross-Functional Team Leadership
• Supplier Quality
• Extrusion
• Iso 9000
• R&D
• Quality System
• Process Simulation
• Continuous Improvement
• Process Engineering
• Supply Chain
• Lean Manufacturing
• Value Stream Mapping
• Process Improvement
• Quality Control
• Dmaic
• Manufacturing Engineering
• Semiconductors
• Powder X-Ray Diffraction
• Materials Science
• Failure Analysis
• Engineering Management
• Materials
• Plastics
• Electronics
• Manufacturing Operations
• Kaizen
• Engineering
• Production Planning
• Minitab
• Quality Management
• Coatings
• Supply Chain Management
• Process Optimization
• Spc
• Design of Experiments