Manager Medical Device
Resume:
Ronald B. Cabral
619-***-**** I *******@******.***.*** I linkedin.com/in/ronald-cabral-58b93767
PRODUCTION AND DEVELOPMENT MANAGER
Experienced Production and Development Professional with a demonstrated history of working in the medical device industry. 9 years of progressive experience across a broad range of Manufacturing functions and diverse industry segments. Skilled in Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Protein Chemistry, Medical Devices, Research and Development, Validation, and ISO 13485. Strong operations professional with a Bachelor's degree focused in Chemistry from UC Irvine. Areas of expertise include:
o Product Development
o Lean Manufacturing
o Lateral Flow/Point of Care
o Validation
o Team Building
o Design Control
o Communication
o Product Improvement
o Research and Development
o Protein Chemistry
o GMP/GDP
o ISO 13485
o CAPA/NCMR/DR
o Scheduling/Delegation
o Fish Bone Analysis
PROFESSIONAL EXPERIENCE
BIOMERICA INC., Irvine, CA 2011-2018
Production and Development Manager
Hired as a Production Technician to assist in lateral flow development, RnD projects, inventory management, and product improvement. Quickly promoted to Production and Development Supervisor within a year, then as Production and Development Manager four years later. Managed a production and research team of five in Irvine, CA and established supervision and communication with a manufacturing team of 25 in Mexicali, Mexico. Initiated all Deviation reports, Corrective and Preventative Action reports, and Non-conforming Materials report. Traveled to Mexicali at least once a month for equipment validations, internal and external audits, and team training. Incorporated fish-bone analysis for troubleshooting and attended and participated in all weekly production meetings, staff meetings, monthly management reviews, bi-annual management review board, and yearly fiscal budgeting and strategy. Key Contributions:
Improved methods for increased production output from 60K to 500K units. Constructed new techniques and procedures that allowed for scale up manufacturing without adding additional production cost/labor all while maintaining product quality.
Developed new product utilizing Design Control for Medical Devices. Completed all design input and outputs, verification and validation, and transfer to production. In the process of completing post-market surveillance.
Spearheaded the modernization of two 40+ year old products to meet current medical device standards. Update procedures with a complete overhaul of manufacturing,in-line testing, and QC qualification.
Prepared for an audit that lead to the outcome of zero non-conformances. Prepared extensively for the audit that would meet the CE requirements according to ISO 13485. BIOLEGEND, San Diego, CA 2009-2011
Production Technician
Hired as a third member of a production team. Performed purification of IgG and IgM antibodies by following batch records, maintaining and analyzing lot histories for trends analysis, as well as performing analytical instrument maintenance and troubleshooting. Use of affinity and sizing column. Reworking failed clones. Test for purity by SDS Page gel, IEF gel, and LAL endotoxin.
Key Contributions:
Improved methods and created new techniques for increased production. Increased affinity column sizes and developed a method of utilizing overnight affinity procedures. Production batches increased from 100g yields to up to 1000g yields.
Spearheaded new procedure of purifying IgE antibodies. Performed multiple experiments to optimize pH, flow, and outputs IgE antibodies.
Given supervisor's responsibilities when on maternity leave. Responsible for schedules, delegation of work, and attended all Manager meetings for three months. ORANGE COUNTY WATER DISTRICT, Fountain Valley, CA 2005-2007 Intern
Assisted Chemist with laboratory procedures dealing with HPLC, GC/MS, and GMP regulations. Responsibilities included reagent and acid preparation, maintaining demonized water systems, maintained laboratory chemical and physical inventory. Achieved lead intern and managed an internship group. Key Contributions:
Achieved lead intern and managed an internship group. Delegated responsibilities and prepared weekly schedules for two interns.
Developed written procedures for all intern responsibilities. EDUCATION AND TECHNICAL PROFICIENCIES
Bachelor of Science (BS) in Chemistry (2007)
UNIVERSITY OF CALIFORNIA, IRVINE
Technical Skills
Mac, PC, Linux, MathCAD, Spartan, Internet Research, File Maker, MRP Microsoft Office (Word, Excel, Power Point, Outlook), Microsoft Visio
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