Andres Ledesma
Irvine,CA
Summary
Hand on Principal Engineer/Project Manager/ Director QA / Senior QA Manager with experience in Medical Device. Aerospace, Military, Electronics industry. Strong background in creating and/or maintaining quality management systems (QMS) based on ISO 9000/13485/AS 9100 and in coordinating continuous improvement programs using Lean Manufacturing and/or Six Sigma Principles. Proven capabilities in leadership. Dedicated, positive, realistic thinker, and open-minded individual. Enjoy working with people in environments, independently and/or as part of a team. Welcome challenges and the opportunity to acquire proficiencies. Drive to fully understand how things work by doing research and using personal resources.
Overview
28
28
years of professional experience
Work History
Principal Engineer/Project Manager
Edwards Lifesciences
04.2022 - Current
- Company Overview: (Medical Device) Website: [edwards.com](https://www.edwards.com)
- Collaborate in the Quality Management System for functional areas including Design Controls, Risk Management, Corrective and Preventative Action (CAPA) and Non-Conforming Material Reports
- Participate in the implementation of design and development documents, quality system procedures, laboratory documentation and controls, and validation: TMVs, Process Characterization, IQ/OQ/PQ
- Collaborate on internal/external policies/SOPs to ensure compliance with regulations and standards
- Participate in regulatory support relating to design, manufacturing process, and product documentation
- Support FDA/DEKRA, EW finance internal and SOX audits
- Carry out Audits and supplier’s certification
- Participate in the establishment and compliance of Risk Management program based on ISO 14971
- Author of the documentation for Extrusion, Plastic & Silicone Validation Process Including Procedures, Flow Charts, Guidelines and Templates
- Participate in CAPA, Risk Management, and Validation Boards/programs
- Facilitate Microbiology, Biology and Chemistry project testing as project sponsor
- Oversaw the approval of protocols/reports for EW Worldwide Engineering projects
- Controlled project design compliance to DFX, GXP and according to FDA, MDR regulations
- (Medical Device) Website: [edwards.com](https://www.edwards.com)
Staff Engineer/Project Manager
Edwards Lifesciences
03.2021 - 03.2022
- Company Overview: (Medical Device) Website: [edwards.com](https://www.edwards.com)
- (Medical Device) Website: [edwards.com](https://www.edwards.com)
Senior Engineer/Project Manager
Edwards Lifesciences
12.2021 - 02.2021
- Company Overview: (Medical Device) Website: [edwards.com](https://www.edwards.com)
- (Medical Device) Website: [edwards.com](https://www.edwards.com)
Project Manager
Maetrics Compliance Agility + Global acumen
09.2014 - 05.2015
- Company Overview: (Contract) Website: [maetrics.com](https://www.maetrics.com)
- Project Manager Quality System Simplification Program of a Major Medical Device Manufacturer with over 3,400 procedures Identified
- Oversaw Eight QSE’s of a total 34 QSE’s + 1 Refine Simplification + 3 QSE’s in last stages
- Orchestrated with Sponsors in the preparation of Project Charter and Project Approval Process
- Supervised meetings/communication within BC (R&D, QA, RA, etc.) & between (BC/Suppliers)
- Directed Kaizen events, Presentation and Reports
- Authored/directed project schedules, risk identification and developed contingency plans
- Orchestrated project plans to optimize resources and coordinated team meetings
- Authored implementation and communication Plans
- Facilitated the PMO on updating the Overall Project WBS and the Quality System Simplification Master Document Inventory Data base
- (Contract) Website: [maetrics.com](https://www.maetrics.com)
Senior QA/RA Manager
JG Plastics Group, LLC
Costa Mesa, Calif.
12.2012 - 08.2014
- Company Overview: (Medical Device/Aerospace) Website: [jgplastics.com](https://www.jgplastics.com)
- Authored/implemented/directed the Quality Management System for functional areas including Design Controls, Risk Management, Corrective and Preventative Action (CAPA)
- Authored/implemented/directed the design and development documents controls, and validation processes: TMVs, Process Development, IQ/OQ/PQ
- Authored/implemented/directed the internal and external regulatory policies and procedures to ensure compliance with applicable regulations and standards
- Directed internal external audit program including FDA/Nadcap, BSI, customers & suppliers audits
- Directed internal/external customer satisfaction by overseeing Quality initiatives and KPI’s
- Directed the CAPA, Risk Management, and Validation processes
- Carried out the organization’s post-launch surveillance, proficiency testing, and implementation of continuous improvement of the quality system
- Upper Management Quality System representative
- (Medical Device/Aerospace) Website: [jgplastics.com](https://www.jgplastics.com)
Senior QA/RA Manager
Umeco Structural Materials/Cytec
Huntington Beach, Calif.
09.2010 - 12.2012
- Company Overview: (Medical Device/Aerospace) Website: [umeco.com](https://www.umeco.com)
- Authored/implemented/directed the Quality Management System for functional areas including Design Controls, Risk Management, Corrective and Preventative Action (CAPA)
- Authored/implemented/directed the design and development documents controls, and validation processes: TMVs, Process Development, IQ/OQ/PQ and PPAP
- Authored/implemented/directed the internal and external regulatory policies and procedures to ensure compliance with applicable regulations and standards
- Directed regulatory support relating to labeling, promotional material, and product documentation
- Directed internal/external customer satisfaction by overseeing Quality initiatives and KPI’s
- Directed the CAPA, Risk Management, and Validation Boards/programs
- Carried out the organization’s post-launch surveillance, proficiency testing, and implementation of continuous improvement of the quality system
- Controlled compliance of the Risk Management System
- Directed internal external audit program including FDA/Nadcap, TUV, customers & suppliers audits
- Authored Procedures, WI, Inspection Plans, Cost Estimates & Technical Quality Plans for Proposals
- Directed COQ using analytical and statistical data
- Directed risk identification and development of contingency plans
- Controlled project design compliance to DFX, GXP and according to FDA, MDR regulations
- (Medical Device/Aerospace) Website: [umeco.com](https://www.umeco.com)
Director QA/RA/R&D
Pentair Pool and Spa
Chino, Calif.
11.2007 - 09.2010
- Company Overview: (Consumer Goods) Website: [pentair.com](https://www.pentair.com)
- Authored/implemented/directed the Quality Management System for functional areas including Design Controls, Risk Management, Corrective and Preventative Action (CAPA)
- Authored/implemented/directed the design and development documents controls, and validation processes: TMVs, Process Development, IQ/OQ/PQ
- Authored/implemented/directed the internal and external regulatory policies and procedures to ensure compliance with applicable regulations and standards
- Directed regulatory support relating to labeling, promotional material, and product documentation
- Directed internal/external customer satisfaction by overseeing Quality initiatives and KPI’s
- Directed the CAPA, Risk Management, and Validation Boards/programs
- Carried out the organization’s post-launch surveillance, proficiency testing, and implementation of continuous improvement of the quality system
- Directed QA/RA/R&D department CAPEX/OPEX budgeting
- Directed COQ using analytical and statistical data
- Directed risk identification and development of contingency plans
- Upper Management Quality System representative/Executive QA Manager of Rainbird
- Directed internal external audit program including NSF/UL/AIMPO, customers & suppliers audits
- (Consumer Goods) Website: [pentair.com](https://www.pentair.com)
Senior Principal QA Engineer
Hi Tech Group/Parker Hannifin
Anaheim, Calif.
11.2005 - 11.2007
- Company Overview: (Medical Device/Aerospace) Website: [parker.com](https://www.parker.com)
- Authored/Updated/supervised of the QMS
- Orchestrated interplant audits based on ISO 9001/13485 and AS 9100
- Authored testing/inspection requirements based on aerospace, MIL, and medical device standards
- Authored/documented GMP/FDA compliant validation protocols/reports: TMVs, Process Development, IQ/OQ/PQ and/or PPAPs
- Authored control methods documented in control plans, d/pFMEAs
- Supervised supplier audits and certifications
- Supervised real time SPC process
- Facilitated customer, ISO 9001/13485, UL, CE, and Regulatory Agency audits
- Orchestrated project design compliance to DFX, GXP and according to FDA, MDR regulations
- Supervised the CAPA, Risk Management, and Validation processes
- (Medical Device/Aerospace) Website: [parker.com](https://www.parker.com)
Senior Principal QA Engineer
Nypro
San Diego, Calif.
09.2004 - 11.2005
- Company Overview: (Medical Device/Aerospace) Website: [nypro.com](https://www.nypro.com)
- Authored/Updated/supervised of the QMS
- Orchestrated interplant audits based on ISO 9001/13485 and AS 9100
- Authored testing/inspection requirements based on aerospace, MIL, and medical device standards
- Authored/documented GMP/FDA compliant validation protocols/reports: TMVs, Process Development, IQ/OQ/PQ and/or PPAPs
- Authored control methods documented in control plans, d/pFMEAs
- Supervised supplier audits and certifications
- Supervised real time SPC process
- Facilitated ISO 9001/13485, UL, CE, certifying entity, and customer audits
- Orchestrated project design compliance to DFX, GXP and according to FDA, MDR regulations
- Supervised the CAPA, Risk Management, and Validation processes
- (Medical Device/Aerospace) Website: [nypro.com](https://www.nypro.com)
Director QA/RA
The Tech Group
Guadalajara, Mexico
11.2000 - 08.2004
- Company Overview: (Medical Device/Aerospace) Website: [techgroup.com](https://www.techgroup.com)
- Authored/implemented/directed the Quality Management System for functional areas including Design Controls, Risk Management, Corrective and Preventative Action (CAPA)
- Authored/implemented/directed design/development documents controls, and validation processes: TMVs, Process Development, IQ/OQ/PQ
- Authored/implemented/directed the internal and external regulatory policies and procedures to ensure compliance with applicable regulations and standards
- Directed regulatory support relating to labeling, promotional material, and product documentation
- Directed internal/external customer satisfaction by overseeing Quality initiatives and KPI’s
- Directed the CAPA, Risk Management, and Validation Boards/programs
- Carried out the organization’s post-launch surveillance, proficiency testing, and implementation of continuous improvement of the quality system
- Directed QA/RA department CAPEX/OPEX budgeting
- Directed COQ using analytical and statistical data
- Directed risk identification and development of contingency plans
- Upper Management Quality System representative
- Directed internal external audit program including FDA/Nadcap, BSI, customers & suppliers audits
- (Medical Device/Aerospace) Website: [techgroup.com](https://www.techgroup.com)
Director QA/RA/R&D
Interlub / Interglass
Guadalajara, Mexico
06.1996 - 11.2000
- Company Overview: (Medical Device/Aerospace) Website: [interlub.com](https://www.interlub.com)
- Authored/implemented/directed the Quality Management System for functional areas including Design Controls, Risk Management, Corrective and Preventative Action (CAPA)
- Authored/implemented/directed design/development documents controls, and validation processes: TMVs, Process Development, IQ/OQ/PQ
- Authored/implemented/directed the internal and external regulatory policies and procedures to ensure compliance with applicable regulations and standards
- Directed regulatory support relating to labeling, promotional material, and product documentation
- Directed internal/external customer satisfaction by overseeing Quality initiatives and KPI’s
- Directed the CAPA, Risk Management, and Validation Boards/programs
- Carried out the organization’s post-launch surveillance, proficiency testing, and implementation of continuous improvement of the quality system
- Directed QA/RA/R&D department CAPEX/OPEX budgeting
- Directed COQ using analytical and statistical data
- Directed internal/external audit program including FDA, TUV, customers & suppliers audits
- Upper Management Quality System representative
- (Medical Device/Aerospace) Website: [interlub.com](https://www.interlub.com)
Education
MBA - Project Management
Capella University
07.2011
BSc - Chemistry
University of California, at Los Angeles (UCLA)
Westwood, Calif.06.1990
Skills
- Bilingual: English and Spanish
- Project Management
- Kaizen improvement events and methodology
- VSM
- Takt T/T
- Cycle Time
- 5S
- SQDCC Tools
- ISO 9001/13485
- AS 9100
- 21 CFR 820
- IQ
- OQ
- PQ validations
- Product and Process Approval (PPAP)
- Failure Mode Effect Analysis (FMEA)
- Test Methods
- TMVs/MSAs/Gage R&R
- Minitab
- Microsoft Projects
- GMP
- Lean Manufacturing
- Six Sigma
Careersummary
Hand on Principal Engineer/Project Manager/ Director QA / Senior QA Manager with experience in Medical Device. Aerospace, Military, Electronics industry. Strong background in creating and/or maintaining quality management systems (QMS) based on ISO 9000/13485/AS 9100 and in coordinating continuous improvement programs using Lean Manufacturing and/or Six Sigma Principles. Proven capabilities in leadership. Dedicated, positive, realistic thinker, and open-minded individual. Enjoy working with people in environments, independently and/or as part of a team. Welcome challenges and the opportunity to acquire proficiencies. Drive to fully understand how things work by doing research and using personal resources., English, Spanish, Successfully directed multiple projects/products and performed cost savings analysis., Kaizen improvement events and methodology: VSM, Takt T/T, Cycle Time, 5S, and SQDCC Tools., Excellent verbal/written communication skills., Proven leadership skills., Work well with others, responsible, passionate/quick learner, innovative, motivated thinker., ISO 9001/13485, AS 9100, 21 CFR 820, Project Management, IQ, OQ, PQ validations, Product and Process Approval (PPAP), Failure Mode Effect Analysis (FMEA), Test Methods, TMVs/MSAs/Gage R&R, Minitab, Microsoft Projects, GMP, Lean Manufacturing, Six Sigma
Other
- UCLA Chemists Association
- American Society for Quality (ASQ)
Languages
Spanish
Professional
Timeline
Principal Engineer/Project Manager
Edwards Lifesciences
04.2022 - Current
Senior Engineer/Project Manager
Edwards Lifesciences
12.2021 - 02.2021
Staff Engineer/Project Manager
Edwards Lifesciences
03.2021 - 03.2022
Project Manager
Maetrics Compliance Agility + Global acumen
09.2014 - 05.2015
Senior QA/RA Manager
JG Plastics Group, LLC
12.2012 - 08.2014
Senior QA/RA Manager
Umeco Structural Materials/Cytec
09.2010 - 12.2012
Director QA/RA/R&D
Pentair Pool and Spa
11.2007 - 09.2010
Senior Principal QA Engineer
Hi Tech Group/Parker Hannifin
11.2005 - 11.2007
Senior Principal QA Engineer
Nypro
09.2004 - 11.2005
Director QA/RA
The Tech Group
11.2000 - 08.2004
Director QA/RA/R&D
Interlub / Interglass
06.1996 - 11.2000
MBA - Project Management
Capella University
BSc - Chemistry
University of California, at Los Angeles (UCLA)
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