Quality Assurance Manufacturing Team
Resume:
SUMMARY
Manufacturing Operations Lead with over 20 years’ experience developing and manufacturing medical devices in the medical device industry including 18 years in a leadership position. Extensive background supporting new product, R&D, and process development teams. Broad knowledge of medical device industry regulations including: Quality System Regulations (QSR), 21CFR820, and ISO 13485. A confident leader that works well in a team environment.
Proven ability to increase efficiency by successfully managing, evaluating, and documenting operations.
Demonstrated ability to integrate engineering requirements and improve products.
Effective communicator (both written and verbal), trainer, leader, and team builder dedicated to achieving goals.
Proven ability to work independently or as a team member.
Understanding of measurement techniques and metrology: Caliper, Micrometer, Pin Gauges, Optical Comparator.
Bilingual in English and Spanish.
Employment History
Manufacturing Lead Mar 2020-Mar 2022
Zense-Life
Leads manufacturing toward department metrics.
Allocates resources for manufacturing.
Addresses line down scenarios.
Conducts problem solving techniques to find root causes for processes.
Utilizes effective communication and performance management to supervise, train, evaluate, and motivate a member manufacturing team (operators).
Developed and presented daily/weekly reports on production output, goals, and issues.
Trained personnel on new processes, equipment, and GMP.
Hired and developed additional personnel to efficiently meet more demanding marketing forecasts.
Resolves line issues and suggest improvements.
Operates all manufacturing line equipment.
Conducted QC inspection of final assemblies prior to release.
Completed final QC on Lot History Records (LHRs).
Accomplishments
Worked closely with manufacturing and R&D engineers on process.
Built prototypes and samples for R&D.
Worked closely with engineers on new product design and building/implementing fixtures for manufacturability.
Formulation Specialist 1 Feb 2018-Mar 2020
Genmark Inc.
Formulated reagents for manufacturing.
Excecuted validation studies.
Executed test protocols.
Training on chemicals, formulations, and equipment.
Resolved line issues and suggest improvements.
Operated all manufacturing line equipment.
Assembled cartridges and reagent kit components.
Accomplishments
Worked closely with manufacturing and R&D engineers on process.
Built prototypes and samples for R&D.
R&D Technician Sept 2017-Feb 2018
Apollo Medical Extrusion
Conducted QC inspection of final assemblies prior to release.
Assembled Micro catheters for prototypes and for R&D.
Ensured compliance with manufacturing instructions, product specifications, and regulations.
Braiding, coiling, laminating, varying pitch and durometer, pull wire fabrication, tipping, and skiving catheters.
Supported manufacturing builds from start to finish including labeling, packaging, and delivery to Quality Assurance for product release.
Accomplishments
Worked closely with R&D engineers on process improvement and gave input on implementing fixtures for manufacturability.
Built prototypes and conducted tests on new devices.
Manufacturing Supervisor May 2012 to Feb 2015
Obalon Therapeutics
Conducted QC inspection of final assemblies prior to release.
Completed final QC on Lot History Records (LHRs).
Performed data collection for process improvements.
Trained personnel on new processes, equipment, and GMP.
Utilized effective communication and performance management to supervise, train, evaluate, and motivate a 13 member manufacturing team (operators).
Developed and presented daily/weekly reports on production output, goals, and issues.
Hired and developed additional personnel to efficiently meet more demanding marketing forecasts.
Ensured compliance with manufacturing instructions, product specifications, and regulations.
Organized and maintained floor area and supplies used during work.
Supported manufacturing builds from start to finish including labeling, packaging, and delivery to Quality Assurance for product release.
Maintained training records for all assemblers.
Accomplishments
Consistently met or exceeded production goals/schedules while maintaining high quality standards.
Increased production from 20 devices/day to over 80 devices/day.
Presented a plan to increase production from 20 devices/day to over 150 devices/day.
Worked closely with engineers on new product design and building/implementing fixtures for manufacturability.
Manufacturing and R&D Lead Feb 2000 to June 2004
Intraluminal
Applied expert communication and performance management to supervise, train, evaluate, and motivate a 12 member manufacturing team (operators, leads).
Trained personnel on new processes, new products, equipment, and GMP.
Developed and presented weekly reports on production output, goals, and issues.
Ensured compliance with manufacturing instructions, product specifications, and regulations.
Accomplishments
Worked closely with R&D engineers on process improvement and gave input on implementing fixtures for manufacturability.
Built prototypes and conducted tests on new devices.
Worked closely with engineers on new product design.
Manufacturing Assembler/Lead Mar 1997 to Jan 2000
ICU Medical
Employed effective communication and performance management to supervise, train, evaluate, and motivate an 8 member manufacturing team (operators, leads).
Presented daily reports on production outputs and issues.
Trained personnel on new processes, equipment, and GMP.
Managed and coordinated production to meet milestones.
Ensured compliance with manufacturing instructions, product specifications, and regulations.
Performed daily troubleshooting activities on process issues and implemented corrective actions.
Accomplishments
Responsible for the operation of 10 robots on the assembly line.
Composed valuable documentation of devices including process instructions and training logs.
Manufacturing Lead Feb 1994 to Mar 1997
Micro Therapeutics
Assembled catheters using a microscope.
Conducted in-process inspection.
Used measurement devices: calipers, pin gauges, snap gauges, and micrometers.
Performed set ups on automatic and semi-automatic machines.
Ensured compliance with manufacturing instructions, product specifications, and regulations.
Accomplishments
Responsible for multipile catheter products with different sizes and lengths.
Education
Universidad Autonoma de Mexico (UAM), Quimico-Biologico, 1 year
Instituto Latino de Mexico (ILM) Quimico-Biologico, graduate
Additional Skills
Knowledge of Microsoft Word / Excel
Contact this candidate