Louie Palencia
Kent,WA
Summary
Precise Quality Assurance Manager proficient in all QA operations, policies and procedures. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
Overview
19
19
years of professional experience
Work History
Quality Assurance Quality Control Manager
Paroscientific, Inc
01.2019 - Current
- Audited Quality Management System to maintain compliance to ISO 9001 as well as current good manufacturing practices (CGMP)
- Audited customers, contract manufacturers and suppliers to make sure products, components, mechanical tooling and manufacturing process met requirements
- Manage the material review board (MRB) and non-conformance program to include investigation
- Manage the Quality Assurance corrective and preventive actions program (CAPA); as well as developing corrective actions and monitor the implementation
- Reduce cost of poor quality by 15% by leading failure investigations, conduct root cause analysis and perform corrective actions
- Certified our company to be compliant under Government Industry Data Exchange Program (GIDEP)
- Lead the Quality Engineering team in establishing counterfeit electronic part avoidance, detection, disposition program
- Used lean manufacturing techniques to improve on-time-deliver from 60% to 100% on time to customers
- Represented quality department as cross-function team lead for product portfolios and new product development project
- Ensured that the products met quality and reliability requirements before they were released to customers
Quality Assurance Test Engineer
L'Oréal
12.2017 - 12.2019
- Completed, tracked and managed all documentation associated with directed and implied assignments and designs
- Developed and executed comprehensive test plans and workforce breakdown structures for complete systems for both mechanical and electrical device testing
- Developed and ensured adherence to testing standards and best practices
- Reviewed, evaluated, and identified requirements for testability
- Composed and edited work instructions for quality and test procedures
- Coordinated scheduling of available resources to operations including testing and equipment maintenance
- Traveled to Guangzhou, China to oversee, assist, and support manufacturing line transfer
- Trained 5 test technicians and 10+ operators on test hardware and software
- Provided continuous support for new manufacturing line from a quality standpoint
- Tested hardware and software within tightly controlled tolerances prior to release to production
- Analyzed test results and prepared high-level evaluation reports to present to management teams
- Provided technical advice to influence and improve quality of the product and of engineering practices
- Collaborated with scientific, engineering, and technical personnel to resolve testing problems and provide solutions to improve the quality of the product
- Managed development and implementation of first semi-automatic device life- cycle testing system
- Provided QA support within a quality program compliance to FDA/cGMP requirements Title 21 CFR 210/211 as well as ICH Guidance
- Reviewed assembly documentation in Quality Management System (QMS) to identify necessary changes in simulation and support capabilities
- Ensured that the products met quality and reliability requirements before they were released to customers
- Spearheaded leading the cross-functional team (including marketing, finances, design, supply, manufacturing, warranty, etc.) in new product new product introduction (NPI) process
- Completed, tracked and managed all documentation associated with directed and implied assignments and designs, Developed and executed comprehensive test plans and workforce breakdown structures for complete systems for both mechanical and electrical device testing
- Developed and ensured adherence to testing standards and best practices
- Reviewed, evaluated, and identified requirements for testability
- Composed and edited work instructions for quality and test procedures
- Coordinated scheduling of available resources to operations including testing and equipment maintenance
- Traveled to Guangzhou, China to oversee, assist, and support manufacturing line transfer
- Trained 5 test technicians and 10+ operators on test hardware and software
- Provided continuous support for new manufacturing line from a quality standpoint
- Tested hardware and software within tightly controlled tolerances prior to release to production
- Analyzed test results and prepared high-level evaluation reports to present to management teams
- Provided technical advice to influence and improve quality of the product and of engineering practices
- Collaborated with scientific, engineering, and technical personnel to resolve testing problems and provide solutions to improve the quality of the product
- Managed development and implementation of first semi-automatic device life- cycle testing system
- Reviewed assembly documentation in Quality Management System (QMS) to identify necessary changes in simulation and support capabilities
Calibration Coordinator & Equipment Manager
12.2017 - 12.2019
- Increased organizational productivity by ensuring the calibration of test equipment at specified intervals
- Ensured that equipment was appropriately logged, labeled, and removed from service as appropriate, so that the calibration status would be readily identifiable on the equipment and in the calibration database
- Scheduled and monitored calibration activities with calibration vendor, including equipment repair
- Reviewed ISO/IEC 17025 medical and non-medical level calibration records for accuracy, completeness and taking action(s), as appropriate
- Ensured investigations for any Out of Tolerance (OOT) events were completed within established periods
- Improved budgeting by implementing standardized operations for all locations through equipment management
- Monitored equipment and tool inventory to consistent replenishment in alignment with demand
- Performed routine and preventative maintenance on ISO 13485 /IEC 17025 medical and non-medical test equipment
Electrical Engineer
09.2014 - 11.2017
- Qualified new PCBA supplier for multiple devices of Clarisonic
- Managed manufacturing projects and program services to handle engineering and project metrics
- Reviewed products for compliance with Design for Manufacturing (DFM) requirements
- Developed streamlined manufacturing process, which boosted productivity and improved budgeting
- Used lean manufacturing principles such as Six Sigma and 5S to develop, evaluate, and improve manufacturing methods
- Applied agile methodology to shorten cycle time and achieve target margins
- Designed electrical testing for verification and validation to be implemented in the manufacturing process
- Performed tolerance analysis to ensure success in high-volume product manufacturing
- Investigated reports of defective, damaged or malfunctioning parts, assemblies, equipment and systems
- Transferred data for engineering drawings, standards, specifications and manufacturing instructions and procedures to decrease administration time and hard copy resources
- Trained 5+ floor technicians and 10+ operators on production and company processes
- Collaborated with various departments such as engineering, management, procurement, sales, marketing, suppliers and quality assurance to provide technical support
- Nintendo
- Failure/Root Cause Analysis Specialist
09.2013 - 09.2014
- Worked with test engineers to execute and improve test coverage
- Assisted in developing test methodology to check product features and devised test plans
- Determined and recommended test methods to address improvement opportunities
- Provided observations, took measurements and performed tests at various stages according to quality control plan
- Followed quality standards and procedures to minimize testing errors and maximize customer satisfaction
- Increased customer satisfaction and repeat business through relentless pursuit of resolutions to problems arising
- Established and maintained productive working relationships with staff to resolve operational difficulties and to promote interdisciplinary, collaborative approach to customer service provision
- Identified and resolved process issues to encourage smoother procedures, more efficient workflow and overall business growth
Sergeant, Squad Leader, Avionics Mechanic
Army National Guard
01.2006 - 01.2012
- Serviced UH-60L Blackhawk and CH-47D Chinook rotary aircraft systems
- Reduced expenditures by repairing systems through technical manuals and minimizing aircraft equipment maintenance
- Resolved service-related problems and documented actions in aircraft maintenance system
- Diagnosed faults and developed resolution plans in accordance to military specifications
- Completed preventative and reparative maintenance on aircraft electronics and computer systems
- Tested electrical aircraft systems, components and equipment for compliance with standards and to uncover any malfunctions
- Performed thorough visual and physical inspections of all electrical parts
- Completed quality assurance checks for service work and completed documentation outlining updates
Squad Leader
06.2008 - 09.2009
- Operations Iraqi/Enduring Freedom, Joint Task Force Forward Operations Base, Iraqi
- Led convoy logistics patrols partaking in escort teams and quick reaction forces along Multi National Force West Iraq (MNFWI)
- Supported convoy commanders in establishing and updating Standard Operating Procedures (SOP) and implementing new tactical SOPs
- Briefed high ranking enlisted and officers on readiness, equipment status and enemy locations on basis to enable sound decision making
- Trained in de-escalation and conflict resolution techniques for use in foreign national negotiations and cooperative actions
- Trained 15 man squad teams on emergency situation preparedness in tactical planning, equipment maintenance and weapon on monthly basis
- Identified issues between soldiers and successfully resolved problems through active listening and interpersonal communication
- Assessed battlefield conditions such as terrain and enemy fire effectiveness to organize and deploy team members effectively
Education
Bachelor of Science - BS - Electrical and Electronics Engineering
Central Washington University
2013
Skills
- Quality Management Systems
- Quality Engineering
- Quality Auditing
- Corrective and Preventive Action
- Risk Management
- Process Optimization
- ISO 9001
Languages
Tagalog
Professional Working
Timeline
Quality Assurance Quality Control Manager
Paroscientific, Inc
01.2019 - Current
Quality Assurance Test Engineer
L'Oréal
12.2017 - 12.2019
Calibration Coordinator & Equipment Manager
12.2017 - 12.2019
Electrical Engineer
09.2014 - 11.2017
09.2013 - 09.2014
Squad Leader
06.2008 - 09.2009
Sergeant, Squad Leader, Avionics Mechanic
Army National Guard
01.2006 - 01.2012
Bachelor of Science - BS - Electrical and Electronics Engineering
Central Washington University
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