Quality Manager Continuous Improvement

W Vincent Wang

Cell: 781-***-**** • E-mail: *******.******@*****.*** • E Providence, RI 02914

CORE SKILLS:

Chief Representative of company on ISO9001, IATF/ISO 16949, 21CFR/FDA, ISO13485, ISO14971, cGMP, ISO14001, OSHA & QA/QC. Established ISO 9001 QMS for new manufacturing facilities, wrote all three level ISO9001 documents, trained ISO team members, successfully implemented quality system in the company daily operation.

BSI certified QMS Lead Auditor.

ASQ Certified QMS ISO13485 Auditor.

Leader on CAPA and continuous improvement with critical thinking & strong problem-solving ability. Significantly reduced nonconforming products by leading the team work (such as scrap rate reduced from 10% to less than 2%; or Defect Per Unit reduced from 5 to 1), saved two automotive employers million dollars each.

Excellent professional with 20 years’ experience in products manufacturing, process QA/QC, receiving inspection, IPQC and FQC, nonconforming materials control/MRB, failure analysis and etc.

Implemented Lean Mfg. in three former companies, including new company, gained customer order.

New products launch for GM, VW, Ford, BMW and etc. Expert of APQP and NPI, PPAP, FMEA, control plan, process mapping, MSA (Gage R&R) and SPC. Best expert of new products launches with substantial experience in project management in many industries including automotive industry.

Tremendous experience in using Six Sigma tools and methods, TQM and PDCA in to improve the products quality, seven-steps problem solving, Pareto chart, Histograms, fish-bone diagrams, root cause analysis, 5 why, DOE, control chart & SPC, Minitab.

Quality Director of casting, rolling and extrusion, machining companies.

Implemented Lean Mfg. in three former companies, including new company, gained customer order.

Representative of customer service on quality issues and complaints, leader in RMA and MRB processes, visited many customers including GM, Ford, VW, JLG and etc.

Expert of supplier quality management and improvement, audited and helped hundreds of suppliers.

Substantial experience in global business and operation, 14-year experience in global operations. Managed and supervised multiple Quality Depts. in different countries/locations.

Experience in test of radiographic, X-ray, resonation, SEM and EDS, Instron tensile, micro-hardness.

Trained Quality Manager, Engineers, Technician, Inspectors and Operators.

Created and established ISO9001 QMS, for new starting companies. 5-year experience in medical device.

Dept. managing works for a Depts. of 72 employees, and a Dept. of 40 engineers with several dozen new products projects; been acting DGM supervising 6 Depts. over 200 employees.

Hosting QMS Mgt. Review with President/CEO, issuing new tasks action plan, summarizing results.

Setting up strategic goals and objectives for corporates, implement and evaluate the achievement.

Experience in Products validation and commissioning, MVP, IQ, OP and PQ.

Created weekly metrics reports, and weekly quality data analysis Pareto charts.

Continuous improvement on product quality and cost reduction. Saved million dollars for employers.

Excellent oral and written communication skills. Leader of team work.

Wrote numerous technical papers and technical book published.

Lead Auditor Certification of QMS. Proficient computer skills. Bilingual

CORE COMPETENCES: SKILLS &TRAININGS

Lead Auditor of QMS, ISO9001, TS 16949, 21CFR/FDA, ISO13485, cGMP, ISO 14971, ISO14001, OSHA, QA/QC in Mfg., APQP & NPI, PPAP, FMEA, control plan, process mapping, MSA and Gage R&R. TQM, Lean manufacturing,, PDCA, 7 Step Problem solving, 8D report, control chart, Pareto chart, Histograms, fish-bone diagrams, RCA, CAPA,,DOE,, SPC and Kpc calculation, 5 why,, customer service, RMA, MRB, supplier quality management and improvement, SCAR, PR&R, global business and operation, training, creating QMS documents, for new starting companies, strategic goals and objectives, QMS Management Review with President/CEO. Dept. Mgt. works. Continuous improvement.

FUNCTIONAL EXPERIENCE

PRODUCT QUALITY IMPROVEMENT

Troubleshooting on products quality issues.

Problem resolving to reduce or eliminate nonconforming products.

Create products quality plan.

Set up strict QA/QC in manufacturing process and data records to assure product properties meeting requirements.

Created Procedure documents.

Create Work Instruction/Inspection Instruction.

Set up MRB to review nonconforming products.

Training team members on improving their operating skills and quality control skills.

Troubleshooting to reduce production costs.

Leading teams to work out new QA/QC document to reduce nonconforming products.

COMPANY STRETIGIC PLANNING

Mission

Vision

5 Year Goals/Objectives

Strategies

Projects

Action Plans for Changes

INTERNAL AUDIT/CREATING QUALITY MANAGEMENT SYSTEM

ISO 9001:2015

ISO -TS 16949:2016

ISO13485:2016

ISO14971:2019

Internal 2nd party Audit

3rd party audit coordination

Creating QMS Documents and Implementation

Training

QUALITY MANAGEMENT

Conducted QMS semiannual review meeting with CEO and top management team, summarize in meeting minutes and issue and implement tasks/actions from the meeting minutes, coordinate with functional managers, summarize the results & review them next meeting.

Weekly report of company metrics for top management team to review.

Leader in team works on product quality improvement, troubleshooting, problem solving and cost reduction.

Establish teams for quality improvements or for implementing QMS; and trained the teams.

New Product Launch work with APQP or NPI; new products design improvement.

Led and manage team works on Problem Solving on issues from RMA, MRB, internal audit and etc.

Managed & led internal audit process; coordinate 2nd and 3rd party audits.

CUSTOMER SERVICE ON QUALITY

Being the company representative for all quality related issues, responded customer promptly.

Conduct RMAs process and resolve customer complaints.

Presenting new product development status/results monthly report to customers.

Visiting customers and taking back their issues/complaints; leading team works to resolve the concerns, set up new Work Instructions and Inspection Instruction to meet all the customer requirements.

Writing and communicating to customers with various report forms after the verification of the effectiveness of implemented CAPA, such as DMR, 8D, SCAR or PR&R report.

Responding to customer with 24 hours and visiting the customers with results.

SUPPLIER QUALITY MANAGEMENT

Supplier’s selection, auditing and approval.

Supplier quality management.

Helped suppliers on setting up QA/QC in their process.

Key suppliers Management with score card.

Performing 2nd party audits on suppliers' quality system, wrote a supplier visiting reports for their customer, and helped suppliers on their corrective actions/preventive actions.

Creating new ISO 9001 Procedure for Supplier & First Article Approval, implemented companywide.

Training suppliers on using quality methods/tools

Hosting supplier quality issue team meetings with suppliers on root cause analysis, CAPA decision, implementation and etc.

CONTINUOUS IMPROVEMENT

Company metrics review an analysis.

Set up the lean manufacturing process and Value Steam Mapping.

Periodically review on the products nonconforming reports and decide the action plan through analysis and implement them.

Setting up company 5-year strategic goal/objectives & adjusted annually for higher level.

Created new QMS Procedure/Work Instruction for more perfectly meeting the requirements.

Continuously train the team members for the new quality Standard and new level.

TRAINING

Companywide trainings on QMS and the upgraded standards, ISO 9001, TS16949, ISO 13485 and etc.

Training on troubleshooting and problem-solving methods to team members on improving products quality.

Training to managers, engineers, and quality staff on using various quality tools/methods in their daily performance.

Training to lab technicians, QC inspectors, productions operators on their works by following Work Instructions.

Training to suppliers on Root Cause Analysis, CAPA and other quality methods and tools.

Applying/training on special tools

APQP

PPAP

FMEA,

Control plan,

MSA and Gage R&R,

PDCA,

7 Step Problem solving,

8D report,

7 QC

RCA, 5Why, CAPA,

RMA,

MRB,

SCAR.

PROFESSIONAL EXPERIENCE

Personal Project 2022 August

Writing books on Quality Management System.

Amgen Pharmaceutical, Sr Quality Consultant Mar. – Jul. 2022

Investigate major deviations, trend deviations in Mfg. processes, collect and analyze the evidences/data, interview operating staffs, host team meetings on investigations, including corrections/containments, conduct products impact analysis, decide investigation plans and the implementation, perform causal factors analysis, RCA and CAPA, create investigation report on the deviation. Worked closely with contracted supplier onsite and the supplier providing devices and service to Amgen Mfg. during the investigations.

Takeda Pharmaceutical, Sr Quality Consultant Dec. 2021- Feb. 2022

Worked on Suppliers Quality Management, 21CFR/FDA, ISO13485, ISO14971, cGMP, Supplier Technical/Quality Agreement, with the detailed Procedures of Supplier Development and Approval, requirements and documentations, with tools of TrackWise, Veeva, and Sharepoint.

Johnson and Johnson, Sr Quality Consultant Feb. – June. 2021

Worked on Suppliers Quality Management, Supplier Selection, Evaluation, and Monitoring, Supplier Quality Agreements and Contracts, Quality Management Systems, QA/QC, Supplier Audit and Corrective Actions, Supplier Process Development, Validation and Approval, Supplier Parts Production Approval and Verification. Working on 21CFR/FDA, ISO13485, ISO14971, cGMP Writing and executing test scripts (IQ/OQ/PQ), Suppliers Quality Metrics and Quality Monitoring.

Philips, Sr Quality Consultant Feb. - Mar. 2020

Worked on CAPA projects from customers’ complaints and internal manufacturing nonconforming, RCA, CAPA decisions and implementation, effectiveness verifications for objective evidences, FDA regulations, ISO13485, customers’ complaints, investigations and resolutions investigation reports.

Personal Project 2019

Writing books on Quality Management System.

DCHN, Medical Device Supplier.

Director of Quality Oct. 2017 – Aug. 2018

Worked related to QMS 13485, ISO 9001, QA, QC, QMS, Customer service and customers audits, Supplier Quality Management and developed supplier approval procedure, DMR, MRB, RMA, PM, Data review, training procedure, and etc. CAPA and RCA on gaps in QMS and on customer complained quality issues. Resolved all the complained issues completely with great customer satisfactions. Closed all the 33 gaps in the QMS before starting to upgrade ISO13485 to 2016 standard. Created and modified many Quality Procedures and Work Instructions, trained employees on the new QMS contents, and implemented new procedures and work instructions, upgraded ISO 13485 from 2003 to 2016 Std without any major finding in the third-party renewal audit.

Zimmer Biomet, Medical Device Manufacturer Jul. - Aug. 2017

Braintree, MA

Sr. Supplier Quality Eng

Supplier Quality Management including implementing all QA documents in QMS on Supplier Quality management.

Supplier qualification and approval, and renewal, per the Procedures, documents, samples and audits.

Working with suppliers on SCARs issued, including NCM containment, root cause analysis, CAPA and implementation, verification of effectiveness and etc.

Working on gap, 21CFR/FDA and ISO13485, ISO14971, implementing cGMP and cGDP.

Implementing PPAP+ for changes in products manufacturing on materials, equipment, technology or site/environment.

AEROTEK Oct. 2016 – Apr. 2017

Pawtucket, RI,

Quality Dept. Manager

• Customer complaint analysis and resolution. Team work on root cause analysis; CAPA decision, implementation and verification. Writing report to feedback customers. Permanently corrected and prevented a major complained products defect, and saved a lot of money for the company.

• Manage quality testing inspection of incoming, in-process materials and final products. Set up the nonconforming materials control in Mfg. processes. Prevented NCM to escape to customers.

• Corrective Action team work. Monitoring routine team meetings on open Corrective Actions, managed the team work on the effectiveness of the Corrective Actions.

• Improved ISO 9001 QMS, reviewed and modified the Procedure and Work Instruction. Implemented the quality assurance documents in operations to improve the quality level of the products.

• Team work on eliminating defects in products, and set up the improved production procedure to correct and prevent the defect.

• Participate in new products development works, including the new trial and test data analysis.

Ultra Scientific July - Sept. 2016

N Kingston, RI

Director of QA/RA

Enhance the Company QMS per the three standards: ISO9001, ISO 17025 and Guide 34, ISO13485, FDA and regulations.

Establish the procedures for Quality works including set up new procedure for Internal Quality Audit, QMS Management Review, made annual IQA plan and conducted IQA and QMS MGT Review.

Investigated with customers’ complained quality issues; worked with vendor on the incoming materials quality issue.

SpineFrontier Medical Device Manufacturer June - July 2016

Malden, MA,

Senior Quality Consultant

Improve QMS and implement Procedures, Work Instructions, CAPAs and etc. Establish QMS planning including Quality Objectives and Quality Metrics.

Plan and conduct Internal Quality Audits, QMS Management Review.

Team leader on problem solving, customer complained issues and audits finding; feedback to customers with 8D reports and SCARs.

Working on cGXP, 21CFR/FDA and ISO13485, implementing cGMP and cGDP.

Improve QA/QC in Mfg. and products quality. Work on supplier quality management.

HTP July – Dec. 2015

East Freetown, MA,

Quality Dept. Manager

Set up QA/QC in products Mfg. by creating related documents.

Lead the team work on improving the first pass yield in production, improving welding products quality and reduce the Mfg. cost.

Work on non-conforming materials control and First Article approval.

Worked on nonconforming issues and CAPA; significantly enhanced products First Yield Pass.

Trained quality technicians on inspection works.

Worked on new products development, on RMA analysis and the corrective/preventive actions.

Leach Garner Oct. 2012 – Dec. 2014

Attleboro, MA,

Quality Dept. Manager

Establish QA/QC in stamping, rolling, welding, drawing, investment casting, heat treatment and assembly processes. Set up quality inspection for incoming, in-process materials and final products, and the details of the materials properties and qualities, nonconforming materials control.

Worked on MRB. Investigate customers’ complaints and RMA returned items, and feedback to customers with 8D or SCAR.

Created Quality Alert, SCAR, 8D, Weekly Metrics, Pareto Charts and make improvements.

General Bearing Co May 2011 - Feb. 2012

West Nyack, NY

(Six-month assignment completed, company was inquired)

Director of Tech & Quality Global

Manufacturing process QA/QC improvement, including APQP, PPAP, FMEA, Control Plan, Work Instruction, IQC, IPQC, FQC and OQC. Product quality improvement, nonconforming control, CAPA and continuous improvement, Minitab for data analysis.

Implemented Lean Manufacturing and Kaizen in four JV plants and improved production efficiency.

Enhanced TS 16949. Successfully passed customers’ audits and gained the businesses. Setup lab with ISO17025.

Global business operation with 6 different locations. Conducted audits at multiple locations and worked with teams on the improvement of products quality and Quality Management System.

BROOKS Automation, MA USA Oct. 2010 – April 2011

Quality Management

Lead the team work on customer complained quality issues, root cause analysis, corrective actions implementation, and 8D reports feedback to customers. Weekly tele-meeting with customers discussing customer concerns. Drive the work to close the FACAR and ICAR. Create new procedures for operation process quality assurance and quality control. Interaction with suppliers on nonconforming incoming materials, managed SCAR and supplier quality management.

NESC, Andover, MA USA (Contract) May – Sept. 2010

Quality Management

Leader on electronic device products quality improvement. Worked on customer complaints, internal manufacturing defects, data analysis, root cause identification, CAPA, 8D report, meeting with customers. Resolved all the main quality issues; improve the products quality and the quality system of this electronic instrument manufacturer.

Jumpsource August 2008 – Feb. 2010

MA, USA-(New Mfg. JV started in Dec.2008, closed one year later)

Director of Corporate Quality

Established the Company ISO9001 QMS, created all 3 level ISO9001 documents and implemented in daily operations.

Set up QC/QA of the new Mfg. facility by creating documents of Processing Cards, Materials Travelers, QC Checklist/Record Forms, Work/Inspection Instructions, Flow-charts, shop layout and visual aids.

Designed layouts of the three plant buildings in a lean Mfg. Implemented Lean Mfg. (including all six principles) and Layered Process Audit in the daily Mfg. processes.

Experience in extrusion, forging, heat treatment and coating.

Global operations with customers services and suppliers’ quality management.

BTU International Oct. 2005 – August 2008

MA, USA (Sales turned down, company diverted to Solar industry)

Global Quality Manager

Managed global quality teams in multiple manufacturing facilities. Led three teams working on quality problem solving. and customer complained issues, analyzed root cause and implemented CAPA.

The DPU (Defect Per Unit) found at final test was reduced 5 to 1 after creating new work instructions and visual aids for the operations. Set up ISO9001 system in China manufacturing facility including all three level documents; trained Manager, Engineers & ISO team members.

Write and execute Validation test scripts (IQ/OQ/PQ)

Obtained 0 finding in third party audit in US facilities.

Worked on supplier development and key supplier quality Mgt., visited and audited suppliers globally.

Worked on ERP system. Setup Lean Mfg. in production and use six sigma tools and Lean principles in Mfg. Run the semi-annual QMS review meeting with President/CEO and the top management team. Setup company 5-years strategic plan and reviewed/modified annually.

Worked with all levels of employees and conducted trainings.

REMEC CA, USA (2005) (Telecommunications industry) June- Sept. 2005

Supplier Manufacturing Quality Engineer (Company Acquired)

Worked closely with oversea suppliers to improve the quality of incoming materials/components, also to improve QC/QA system of their manufacturing processes. Visited and followed up the key suppliers to audit and helped to set up their quality system. Trained the suppliers on problem solving methods of quality issues. Helped supplier resolved many quality issues in machining, casting, forming, heat treatment and electroplating. Enhanced the quality assurance documents set up and quality control different stages, which significantly.

Citation Butler, Indiana USA Nov. 2003 – May 2005

(Company filed Chapter 13; plant has been closed)

Primary responsible for reducing the nonconforming products and QA/QC.

Leader in Mfg. process and technologies improvement.

Analyzed the daily production metrics to identify where the non-system variation occurred and the root cause; then implement corrective actions through the team work.

Applied APQP and PPAP process for the automotive component manufacturing.

Used many Six Sigma methodologies, such as 5 why, FMEA, control plan, process mapping, Pareto chart, Histograms, fish-bone diagrams, control chart and SPC, PDCA, Minitab on production metrics and etc.

Conducted internal audit of ISO9001 and layered process audit on daily operation.

Significantly reduced the product scrap rate from10% to less than 2%, which was the history best since the setup of the plant in 1950s, and the company saved million dollars by reducing production cost.

Worked on customer complained quality issues and concerns. Resolved all issues on products quality.

KPSNC Jan. 2002 – Nov. 2003

Shanghai China

(Contracted position, returned to USA)

Technology Dept. Manager/Quality Control Dept. Manager

As the Technology Dept. Head, managed new product developing projects through weekly meeting.

Worked on production floor for troubleshooting on issues of customer complaints, in-process nonconforming, incoming material and the test techniques.

As the QC Dept. Head, set up the new production QC procedures, focused on the nonconforming parts and failure analysis, led the team on root cause analysis and corrective actions implementation.

Significantly reduced the nonconforming products and made the company first time having 9 million RMB (million dollars) profit.

Established with the team work and got certified on both ISO/TS 16949 and ISO14001 system.

Worked on APQP, PPAP, process flow-chart, PFMEA, control plan, MSA and GR&R, SPC and Cpk, work/inspection instructions, and other six sigma methods.

Worked on ejection mold casting and machining of component.

Set up new machining shop for automotive components.

Worked on ERP system.

Visited customers frequently, mainly GM and VW, investigated customer complaints and wrote 8D or PR&R reports.

Director of R&D center and supervised the R&D center with 40s engineers.

Conducted suppliers audit and helped on their quality system improvement; also developed a large Singapore company in Wuxi with 350 CNC machines as the Tier 1 supplier including the training on ISO/TS 169494 system.

YXAF Co., Ltd. (U.S. Alumax J.V.) Kunming, China (Contract completed)

Jan. 1997- Jan. 1999

Director of Technology and Quality (Acting Deputy General Manager)

Set up new processing technology by transferring the technology from an US Manufacturer to a J.V in China. Resolved almost all the major technical and quality issues in the manufacturing process (melting, casting and rolling of alloys.). Managed the team work with semi-weekly team meeting. By the PACD method with team work, the products quality was significantly improved, and technology transfer was completed in a short period. Worked on ISO9001 system, set up operation procedures, conducted troubleshooting on nonconforming issues. Write and execute test scripts (IQ/OQ/PQ). Established Lab for test/inspection and QC inspections, and trained operator and inspectors. Sourced and developed raw materials and utility materials suppliers, conducted supplier audits; worked closely with key suppliers and help them to solve the incoming material quality issues. Visited many customers for sales support; made corrective actions and wrote new QA/QC documents to meet customer requirements.

EDUCATION

Post-Doctoral: Materials/Metallurgical Engineering, University of Toronto, Canada.

Ph. D., Materials/Metallurgical Engineering, McGill University, Canada.

M. Eng., Materials Science and Engineering, Harbin Polytechnic University, P.R.C.

B. Eng., Materials Science and Engineering, Harbin Science and Technology University, P.R.C.

Status: USA Citizenship and Canadian dual Citizenship.

Certificate: Certified Lead Auditor of Quality Management System by BSI and AQS.

LANGUAGE: English, Chinese and French.

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