OBJECTIVE: To obtain a position where I can utilize my work experience and education to improve the company’s operation.
EDUCATION
San Jose High School, San Jose, CA
De Anza College/ Fremont Adult Education- Basic skills and medical training classes
SUMMARY OF SKILLS
Bilingual in Spanish, reading, writing, and speaking capabilities
Strong leadership capabilities and effective communication with team members
CAREER HIGHLIGHTS/QUALIFICATIONS
Solid electronic mechanic assembler
Highly adapted to varying environments
Strong attendance record, always punctual.
Worked effectively in a fast paced environment.
Met demanding deadlines and worked overtime as requested
Highly reliable, flexible, and focused on high quality standards
Strong Problem solving and root cause-trouble shooting ability
Consistently met timelines and standards to complete job objectives
PROFESSIONAL EXPERIENCE
Pacira Pharmaceuticals, Inc 10/2016 - Present
Sr. Manufacturing / Production Assembler
Assists manufacturing team in developing the manufacturing process instructions (MPI)
Responsible in subassemblies and system assemblies for medical device
Supports all assembly/manufacturing related issues including diagnostic, product rework and repair.
Assist for training the new operators and assemblers in device assembly process and testing.
Follow FDA regulations, Good Manufacturing Practices (GMP), general safety and manufacturing procedures, company practices and policies.
Cormatrix, (Manufacturing) Operation Associate April 2012 – December 2015
Responsible for the performance of manufacturing processes, operation of production equipment and in-process inspection of product.
Reporting to the Director of Operations and Quality Systems
Responsible for performance of manufacturing operations including packaging of medical devices, visual inspection and assistance with shipping and administrative activities in a small company environment.
Responsible for executing tasks with minimal supervision and maintaining a high level of accountability for work performed.
Performs product packaging of clinical and commercial products.
Operates production equipment, including but not limited to label printing equipment.
Performs in-process and visual inspections to assure product meets specifications.
Assists with shipping including checking customer orders and packaging for shipment.
Light computer work, filing, scanning.
Ensures that work output and quality meets established standards.
Documents work performed and maintains accurate records to comply with
the FDA Quality System Regulation, ISO 13485:2003 and internal Standard
Operating Procedures.
Responsible for the identification of issues and initiation of actions to prevent the occurrence of any nonconformity’s relating to products, processes, and the quality
Cardiva Medical Assembler, October 2008 –April 2009
Assembled detail assemblies of small parts under a microscope
Performed inspection, and testing of small medical devices.
Followed MPI (Manufacturing Process Instructions.)
Packaging use of labeling and strapping for shipping.
Documented work after inspection accordingly.
Open and close manufacturing orders. Documents work performed and maintains accurate records to comply with the FDA Quality System Regulation, and internal Standard Operating Procedures.
Assigned and perform Re-work instructions.
Assembled various medical devices such as Vascular Closure System, single device to offer collagen and a dual mechanism of action; physiological and mechanical completely. It is a fully integrated, completely bio-absorbable, easy to use vascular closure system.
Xtent, INC., Manufacturing Sub-Assembly II 2006-2007
Packaged medical products for shipping.
Following instructions on MPI, LHR for quantity.
Verifying parts numbers and lot numbers from MPI.
Packaging and boxing, and shipping and receiving labeling, pouching, peel test, using sealer machine, trimming washing parts for R&D.
Working with manufacturing R&D engineering stet stop, sealed the balloon to close the cathedral. Fabricate flushers, pushers coding, style slider section under a microscope using multiple handle attachment.
Assemble medical devices in clean room environment.
Abbot Vascular, Inc., Manufacturing Assembler 2005-2006
Assemble medical devices in clean room such as: vascular closure 9, P8, P10, catheters, stents, etc.
Accessories assembly such as: Suture Trimmer, Clincher, Knot Pusher, etc.
Assemble small, intricate parts using a variety of instruments and fixtures.
Working in molding department as well.
Worked cross functionally with R&D and Engineering.