Rommel Garcia

About Rommel Garcia

Rommel B. Garcia has over 20 years (since 1997) of experience in engineering. He has worked in various fields within product development, testing, sustainability, and quality. His principal expertise is providing all the necessary support in Quality Compliance, Design Engineering, and Technical Sourcing and Manufacturing in the medical device industry. Most recently Rommel has been concentrating in Design Controls, Strategic Planning, and Change Controls. While at Becton, he worked closely with the R&D group for Test Method Development and was responsible for creating new developments and procedures in performing FMEA geared towards End User Risks (EURA) as a result of changes in ISO 14971 and 21 CFR 820. In this role, he was tasked with creating and executing equipment and process validation SOPs for the company.In addition, Rommel also verified and validated Real-Time and Accelerated Aging samples test results and composed reports for the DHF. He performed Risk Assessments hands-on with regard to non-conforming products to determine associated risks to patients with respect to FDA regulations and other standards (ISO14971, IEC 60601-1, IEC 62366, QSR, and ISO13485), developed new test protocols for developing products, and analyzed data using Statistical Software (i.e. Minitab) available. Rommel has developed New Test Methods verified and validated for several Medical Device companies. He was also in charge of enhancing and creating test processes from incoming materials to internal processes (including necessary tooling needed) with cost-effective materials and components. Given his ability to redesign new concepts of an existing product and form a team to fully conceptualize the new design into the current product design Rommel is an excellent and proven SME in Design Controls and risk assessment for medical device development and manufacturing.Recently performed a lecture at a V&V Conference about documentation needs with respect to FDA requirements.Specialties: Test Validation & Verification, VMP, IQ/OQ/PQ, Trace Matrix, GAMP5,(A,D&P) FMEA, Risk Assessment, Design Controls, Risk Management, Root Cause Analysis, MSA, G.R. & R, SPC, CAPA, ICARS, SCARS, ORT, DVT, RDT, Implementation & Audit Surveillance of ISO 9001, 9002, 13485, 5725, 3534, 14971, 60601-1, 21 CFR 820, and CE / EU Standards Auditor-Design of Experiment-Failure Analysis (Elemental, Biological, Electrical, Chemical, and Mechanical)-Test Development / Metrology / CAD (SolidWorks)

Experience

1. Principal Design Quality Engineer Program Manager

   Iridex

   Apr 2017 — Present · US

   Performing remediation on the Risk Management System. Re-establishing Risk Management Files for different devices. Working on qualification of devices on IEC 60••••31 Edition. Modify SOPs and other documents to conform to latest standards and regulations. Program Manager to two new product. Totally changed the Design Control Documentation. Leads the development of major projects.

Education

• University of California, Berkeley

  CNE

• Far Eastern University

  BS, Elect. Eng'g

  1976 — 1979

Skills

• Process Development
• Validations
• 5s
• Regulatory Affairs
• Design of Experiments
• Manufacturing
• 510 K
• Supplier Quality
• Iso 14971
• Engineering
• Testing
• Process Validation
• 21 Cfr Part 11
• Risk Assessment
• Fmea
• Qsr
• Change Control
• Gmp
• Product Development
• Analysis
• Continuous Improvement
• Compliance
• Quality Assurance
• Six Sigma
• Product Launch
• Quality Auditing
• R&D
• Root Cause Analysis
• Spc
• Solidworks
• Quality Engineering
• Metrology
• Medical Devices
• Capa
• Cgmp
• Clinical Trials
• Dmaic
• Doe
• Lean Manufacturing
• Materials