Quality Management Life Cycle

Nellie E Baltazar

**** ******* **. *** *****, Ca 95757 Cell Phone- 408-***-****, E-mail address: ************@***.***

Summary of Experiences:

Establishment, effective deployment and improvements of Quality Management System related to nuclear (10CFR 50/ANSI 45.2), military (MIL Std. 9858), and International Standard such as ISO9001, TL9001, ISO13485(Medical Device Industry), AS9100 (Aerospace). ISO16949 (Automotive), RoHS and REACH from ground Zero to full implementation and ISO QMS .

Course development and conducting training on ISO/TL9000, Internal quality systems/process/life cycle audits, Root Cause Analysis and CAPA, ESD Control, TQM and etc.

Establishments of company quality Objectives or KPI metrics to measure operational output, customer satisfaction and return material analysis, supplier performance, & OBQ used to drive process/systems improvements.

Demonstrated skills and ability to work within matrix organization with strong emphasis on cooperation with inter-departmental and multi-divisional site teams across USA, Germany and Malaysia in defining generic quality management systems that are adoptable for future expansion/acquisitions.

Management of Contract Manufacturers and Supplier, conduct Qualification/Evaluation and Surveillance, and set mutually beneficial quality expectations for improvements.

Certified ISO9001:2008 QMS Auditor by International Register of Certificated Auditor (IRCA) and experienced ISO9001:2008/ISO900:2015 Lead Auditor/Certification Officer for ISO registration with National Standards Authority of Ireland (NSAI, left them in 2017 for full time employment with company).

Setting of quality strategy, goals and objective, quality and safety policies and procedures.

Managed and supervised quality staff, established key performance measures to drive process improvements to enhance customer satisfaction.

Deal with regulatory agency such as the NRC, FDA, and ISO Registrars and Customers during audits.

Considerable experience in working with design and development engineering, and the implementation of the product life cycle process and audits.

Provide technical guidance to quality engineers for Receiving Inspection, WIP, Final inspection, Manufacturing Engineering, Document Control and Supplier Engineering for optical products, PCB/PCBA, semi-conductor, electromechanical assemblies, etc.

Interface with customers in problem resolution of customer returns/issues and drive company continual improvement program

Led a company to achieve silver award in ECOVADIS certification in less than 3 months

PERSONAL STRENGTHS:

Senior management leadership roles, technical and organizational competence in manufacturing operations and quality at multi-sites and divisional levels.

Self-motivated, and good inter-personal skills, excellent communication, presentation & training skills

Demonstrated skills and ability to work within different level of the company, from top to bottom and vice versa.

Goal oriented, attains set objectives in a timely manner, a team player and excellent coach in the establishment/control of various manufacturing/quality processes.

Training module development for QMS, Design and Development Product Life Cycle, Internal Audit Process, CAPA, MRB, Supplier programs/control, RoHS, REACH and CMRT Processes, etc.

ACCOMPLISHMENTS:

Improved 12% margin to 23% which saved a company from bankruptcy.

Voted Who’s Who in America (2021, 2016 in professional Quality discipline)

Took over management of a budget overrun project without incurring further loss.

Led a company to be the first TL9001 certified in North America and led other companies to ISO9001 registrations in less than a year.

Developed a Product Life Cycle Guideline, PLC Procedure and PLC Audit Program for HW/SW development to improve turn-around time and meet fast time to market goals.

Assisted/facilitated in defining program requirements for division information databases for CAR/PAR and RMA processes and other quality data collection system and improved QMS Data Management Systems retention process. Implemented a system that reduced the record maintenance cost by $125K/year.

Improved the relationship between GE with the NRC during surveillance visits through training and good planning.

Authored a guide on continuous improvement program which was deployed across the company.

ASQ Paper Presenter for transition of ISO9001:2000 to ISO9001:2008 while working as Certification officer with NSAI.

PROFESSIONAL AFFILIATIONS:

• Lyten Director, Total Quality System – Dec. /22 to Sept. 2023

• Operation/Quality Director – Dynamic Integrated Solutions (for a Medical Industry) April, 2022 to Nov. 22 on consulting capacity and currently acting in a QMS consulting capacity when needed.

• EMSC Consulting Services – May, 2020 to April, 2022

• Elenion Technologies, LLC: Director of Quality -May 2016 to April 2020

• Oclaro: QMS consultant, then MFG Operations Manager. July/2012 to April 2016

• Capella Intelligent Subsystems, 9/2008 to 6/15/12: Quality Manager

• EMSC Services, 1/2003 to 8/2008: Principal Consultant / contract certification auditor for NSAI

• Sanmina SCI, 8/99 to 8/2002: Director of Corporate Quality Systems 915 PCB facility locations).

• Micro Module Systems -12/97 to 12/98: Corporate Quality Director,

• Tandem Computers (Please note responsibilities "a to c" for a period of 10 years)

o a).SDG Quality Systems Audit Manager (HW Engineering Div.) -1/94 to 12/97

o b) Corp. Quality Consultant/Business Planner-Quality Initiative Center -7/90 - 12/31/93

o c) Quality Information Systems Manager - 8/97 - 6/90

• GTE Government Systems, Mt. View, CA. -8/85 - 7/87: Quality Manager

• Entrepo, Sunnyvale, CA - 5/83 - 2/85: Director of Quality Assurance/Acting Manager of Manufacturing

• Imagic, Los Gatos, California, 5/82 - 4/83: Director of Quality /Acting Manufacturing Engineering Mgr.

• GE Nuclear Energy Control and Instrumentation Division, -

o 5/80 - 4/82: Systems and Supplier Surveillance Manager/Principal Engineer

o 2/76 -3/80: Sr. Quality Engineer (Electrical/electromechanical products)

• Amdahl Corporation – QA Inspection Lead

o 1972 -1976:Computer Assembly, PCB Artwork, Receiving, In-process and Final inspections.

EDUCATION, OTHER DEVELOPMENT COURSES AND PROCIFIENCIES

BS CHEMICAL ENGINEERING, ADAMSON UNIV., PE License - Chem. Engineering - Manila, Philippines

General Electric Manufacturing and Management courses, TICKIT ISO9000-Auditors Training Course, ISO9000, ANSI 45.2 Seminar and Audit training, Statistical Design of Experiments & Fundamentals of Defect Prevention/Statistical Process Control, California Quality Award Examiner Training Course.

IRCA QMS Auditor- # 01188249 (Certified QMS 9001 Auditor by International Register for Certificated Auditor), ISO09001:2000 Lead Assessor Course-BSI(CEEM) 10/04/2002 updated to ISO9001:2008, then updated to ISO9001:2015 PECB in 8-20-2015

OSHA Compliance and Workplace Safety Training

ECOVADIS Implementation Experience

CMRT Implementation, RoHS and REACH.

Self-trained in ECOVADIS Implementation program focused on environmental, safety and employee/supplier/customer social programs for a company.

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REFERENCES: Available upon request

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