Richard M. DiCarlo https://www.linkedin.com/in/richard-m-dicarlo/

ad2w89@r.postjobfree.com +1-817-***-**** Camarillo, CA

Senior Engineer

Chemical Engineering Manufacturing Medical Devices cGMP Lean Six Sigma Green Belt Continuous Improvement

Manufacturing and Regulatory ISO, FDA, MDD, cGMP Compliance Quality Control Optical Microscopy Digital Microscopy SEM/EDS Gas Chromatography DSC and TGA Chemical Testing Destructive Testing Design of Experiments

Investigated new and existing technology, including instruments, methods, and fixtures for medical device testing from development into commercialization. Installed, repaired, maintained, qualified, and validated clinical and discrete scientific instruments to meet company protocol and industry laboratory standards, including ISO, FDA, MDD, and regulations applicable to medical devices/science/technology design and development.

●Project Management – Planned and managed critical and complex projects such as designing innovative test tools and equipment, building and monitoring cGMP-rated laboratories used in medical device manufacturing.

●Technical and Operational Leadership – Provided authoritative technical, professional advice and recommendations to influence stakeholders and external contacts. Coordinated meetings and resources with stakeholders, served as SME to assist cross-functional teams in process development and knowledge transfer.

Career Experience

Quality Operations Manager – ECA Medical Instruments (Jan 2022 – Jan 2024)

Oversaw daily operation of quality control and engineering operations for this medical device manufacturer with full responsibility for implementing operational quality strategy. Deliverables included building a high-performing team and taking ownership of quality initiatives and continuous improvement by optimizing quality systems operations to identify, measure, and reduce costs.

Operations -- Ensured the implementation of the operational quality strategy.

●Compiled, analyzed, and forecasted NCMR (Non-Conforming Material Report) and cost of quality data.

●Evaluated operations quality control capability, identified gaps, and recommended issue resolution to senior management.

Continuous Improvement -- Optimized quality systems operations to effectively identify, measure, and reduce costs.

●Supported the planning pipeline of quality improvement activities, including initiatives to increase product quality, command resolves audit and CAPA decrease in effectiveness, and improve risk management.

●Reviewed and approved change orders to product processes and materials.

●Implemented effective corrective action when non-conformances arise. Ensured effective control of product/process deviations for all related products.

Quality Operations Manager – ECA Medical Instruments (Jan 2022 – Jan 2024) Continued

Employee Development -- Identified, supported, and developed direct reports to achieve business and quality objectives. Fostered an environment of proactive and continuous improvement approach to quality.

Audit Participation - Assisted in preparation of audit documents. Supported the front room of the audit by supplying requested documents. Prepared my staff to be able to address questions asked by the auditor.

Validation - Reviewed, corrected, and approved all IQ, OQ, PQ documents for the company.

●Quality management system.

●Maintained meticulous documentation throughout the qualification process, creating comprehensive reports detailing the execution, results, and any deviations observed during IQ, OQ, and PQ.

●Ensured that all documentation met regulatory standards and could be readily accessed for internal and external audits.

Lead Engineer – Alcon, Fort Worth, TX (Dec 2014 – Dec 2022)

Lead engineer for SEM/EDS operation for the implantables organization. Worked with requesters to image and analyze the composition of unknown materials on delivery devices, IOLs, and subassembly components. Proficient at imaging and chemical composition identification of various materials using a low-pressure vacuum.

Innovation -- Created non-destructive, non-contact automated optical inspection for measuring parts to determine if parts are within specifications. Conducted IQ/OQ/PQ of the instrument and trained technicians on its operation.

●The 100% non-destructive inspection of parts reduced the rate of rejected parts and saved the company +$50,000/year.

●Filed a trade secret for a novel fixture for scanning electron microscopy (SEM) analysis which minimizes the damage of the part under test.

Testing Methods -- Used optical inspection, FITR, RAMAN, SEM, and XRD analysis to determine the composition of a foreign material observed on a delivered IOL (Inter Ocular Lens) tested in a simulated delivery.

●Presented test results and findings that resulted in improvements to the coating procedure and changes to nozzle design– increasing acceptable deliveries.

Quality Assurance -- Created a non-contact confocal microscopy test method to measure surface roughness of IOL delivery nozzles and provide critical QA information to the molders.

●Implemented a cutting system that reduced the time to produce sample parts from minutes to seconds and removed the possibility of injury during sample preparation.

Quality Control Supervisor -- Alcor Petrolab, Arlington, TX (Aug 2013 - Nov 2014)

Performed testing on incoming gasoline, ethanol, diesel, and biodiesel samples. Developed and maintained quality assurance programs, policies, processes, procedures, and controls, ensuring the performance and quality of products conform to established standards and agency guidelines.

SPC/SQC -- Provided Statistical Quality Control tools and training to the lab staff, monitored inspections, statistical process control SPC analyses, and audits to enforce requirements and meet specifications.

●Review and Analysis -- Assessed analytic methods practiced in the lab to ensure compliance with ASTM methods. Reviewed Proficiency Test Program data for accuracy and generated client reports.

●Equipment QA -- Conducted and validated IQ/OQ/PQ on new and existing instruments. Created and executed IQ/OQ/PQ to support the move of 30+ instruments to a new location– led the relocation project.

Scientist/Engineering (Contractor Assignment) -- Alcon Laboratories, Inc. Fort Worth, TX (Aug 2009 – Aug 2013)

Formulated appropriate water content of lens; cast, cured and conducted standard and non-standard testing to determine the physical properties of a new surgical interocular lens.

●Created SOPs for new instruments for testing and built innovative non-standard testing instruments.

Quality Technician/Development Technician -- Solvay Engineered Polymers, Mansfield, TX (Jan 2002 - Feb 2009)

Developed automotive polymer material to meet customer specifications for melt flow, flexural and tensile properties and ensured product quality before releasing to customer.

Continuous Improvement -- Discovered and resolved unexpected material failure rate during the QA tensile strength testing and determined that the quality group's sample conditioning process did not mirror R&D's process.

Additional Experience

Organic Section Leader -- Atomus Labs, Inc., Arlington, TX

Operated GC/MS, GC/FID GC/PID, and UV/VIS spectrophotometer equipment in the laboratory testing of organic samples. Followed EPA and State of TX methods to deliver accurate test results.

Chemist -- CA LABS, Carrollton, TX; Baton Rouge, LA

Created metals testing lab, which included ordering instrumentation, testing supplies, consumables, and calibration standards. Analyzed asbestos samples using Polarized Light Microscopy (PLM), Phase Contrast Microscopy (PCM), and Transmission Electron Microscopy (TEM).

Education and Professional Development

Bachelor of Science, Chemistry, Texas Tech University

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