Quality Engineer Manager

AL BERDUN

PHOENIX, ARIZONA 603-***-**** ********@*****.***

PROFILE

Accomplished QA professional with 20+ years of progressive experience and proven record of significant, successful contribution in quality management, process improvement, business analysis/evaluation, product-development, supplier management, quality management systems, processes, standards, and systems in a wide range of organizations including automotive and aerospace.

Extensive international experience including Canada, Portugal, Japan and México. Aerospace experience including AS9100 and NADCAP audits and certifications. Medical device manufacturing and ISO 13485:2016 experience. AREAS OF EXPERTISE

Quality Assurance Management

Continuous Improvement

Corrective/Preventative Action

Scorecard Development, Tracking and

Reporting

Supplier and Contract Management

Supplier Continuous Improvement

Nadcap Audit Lead

Program/Project Management

Advanced Product Quality Planning

(APQP)

Production Part Approval Process

(PPAP)

Potential Failure Mode & Analysis

(FMEA)

ISO 9001, TS16949, AS9100 Auditor

ISO 13485 : 2016 Implementation

cGMP & GDP / GDocP

Advanced Geometric Dimensioning

&Tolerancing (GD&T)

CQE Certified Quality Engineer

Strong Analytical & Organizational

Skills

Proven experience in problem solving

Ability to initiate and manage change

100% Bilingual – English / Spanish

PROFESSIONAL EXPERIENCE

2017 - 2018 Quality Manager – MedPlast Group – Medical Plastic Injection Molding

Manage & upgrade to ISO 9001:2015, ISO 13485:2016 & 21 CFR 820 Quality systems

Lead and manage all customer and system audits

CAPA: Manage corrective/preventative actions, process improvement and auditing projects

Class I, Class II medical devices and Blood path kits

42% reduction in customer issues

Write and execute OQ and PQ protocols

Track and analyze key performance indicators.

Manage all aspects of Quality department including Continuous Improvement 2016 - 2017 Quality Manager – GW Plastics Inc. – Medical Plastic Injection Molding

Champion, support and lead quality improvement initiatives

Manage and lead the ISO 9001 & ISO 13485 Quality systems

CAPA: Manage corrective/preventative actions, process improvement and auditing projects

Class I, Class II, Class III medical devices and implantable medical devices

Develop and maintain quality performance metrics

19% reduction in customer issues

Manage all aspects of Quality department including 44 direct reports

Lead and manage all customer, system and process audits 2015 - 2016 Quality Manager – Incertec

Restructure, rewrite procedures & Lead Stage 1 & Stage 2 Certification of the AS9100 Quality system

Manage, lead and maintain NADCAP audits and re-certification

CAPA: Manage corrective/preventative actions, process improvement and auditing projects

Track and analyze key performance indicators (KPIs) and metrics.

Identify and Lead Continuous improvement activities

Manage all aspects of Quality department including customers and supplier issues

Implement Lean and 5S initiatives

Al Berdun Page 2

2009 - 2015 Quality Manager – Intec Group Inc. – Precision Plastic Injection Molding

Create, manage, lead and maintain ISO 9001 : TS16949 Quality system

CAPA: Manage corrective/preventative actions, process improvement and auditing projects

Track and analyze key performance indicators (KPIs) and metrics to detect positive and negative trends, recognize training needs, correct procedure deficiencies and optimize operational efficiency.

Chair production meetings for 90 presses running over 400 part numbers, create floor procedures and allocate resources to meet objectives.

98% first submission acceptance for 92 new product launches over 6 years

Manage all aspects of Quality department including 15 direct reports

New product launch with a 22% overall reduction in production issues

28% increase in production achieved through problem solving techniques

Apply proven 6 Sigma problem solving techniques to solve issues 2004 – 2009 Quality Manager / Quality Engineer / Project Manager In a Consultant Role

Improvement Engineer - Arvin Meritor – Puebla, Mexico Objective: Reduce customer complaints using and implement permanent solutions

Eliminated product issues with the primary production product

Implemented Red-X strategies in the problem solving phase and to verify root cause.

Liaisoned with main customer Volkswagen, Puebla to increase understanding and acceptance

Implemented root cause solutions to the production floor

Reduced customer complaints by 96%

Project Manager - Magna – Toluca, Mexico

Objective: Work with supplier to launch and obtain approval for 94 production parts numbers

Managed supplier in an acelerated program launch to meet deadline successfully

100% first submission acceptance for 94 part numbers of “A” surface interior plastic components for the Chrysler JC49 program

Reduced scrap by 36% and increased through put by 22%

Organized and motivated teams to meet the accelerated timeline. Improvement Engineer - Magna - Sterling Heights, Michigan, USA Objective: Improve production lines to increase production and reduce scrap

Restructured production lines completely to one piece flow methodology

Increased throughput of assembly line 70% and decreased quality issues by 60% Improvement / Quality Engineer - Magna – Corporate – New Market, Ontario, Canada Objective: Develop and validate Magni coating as replacement for Trichromate plating

DOE Study to resolve issues with new technology Magni coating for use in all Magna products

Determined the process parameters and flow to ensure a consistent product

Validated the functionality of the Magni coated parts in all Magna/GM assemblies Quality Engineer - Magna – CMP – Bradford, Ontario, Canada Objective: Consolidate, sample, validate and PPAP 600+ stamping dies in one location

Transferred all stampings from 14 plants to consolidate all stamping at Magna CMP

Organized the quality and engineering teams to resolve issues related to the transfers from 12 facilities

PPAPed 600+ tools successfully internally and to the corresponding customers

97% first submission acceptance

Improvement / Quality Engineer - BBi Inc., Sydney, Ohio, USA Objective: Transfer all production from Canada to Sydney, Ohio

Transferred all production from 2 plants in Canada to the new plant in Sydney, Ohio.

Increased production 30%

Decreased quality issues by 43%

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2003 - 2004 Quality Manager, BBi Inc., Cambridge, Ontario, Canada

- Manage department with 12 direct reports.

- Implementation and maintenance of TS-16949 Quality Management System.

- Reduced quality complaints & issues by 96% by solving top issues with DOE study 2001 - 2003 Program Manager / Quality Engineer, Mitchell Plastics, Ontario, Canada

- APQP - Advanced Product Quality Planning for new program launches.

- Launched the GMT191 Program – Equinox (103 A-surface part numbers including painting process)

- Prepare PPAP, PFMEA, Control Plans submissions, any other customer specific quality needs.

- Customer & Supplier liaison for any quality related issues through 8D, determine root cause and prevent reoccurrence

- Ensure tools are available for managing and controlling processes such as SPC charts, gauges and fixtures.

- Co-ordinate and facilitate quality and process improvement projects.

- Proven experience in troubleshooting and problem-solving.

- Created production work cells to minimize WIP inventory, reduce floor space, and improve work flow

2000 - 2001 Quality Engineer, Ventra Plastics, Kitchener, Canada

- Supervise Quality Assurance and Quality Control team.

- Preparation and presentation of sample submissions in Canada and USA plants

- Prepare PPAP submissions, FMEAs, Control Plans.

- Liaison with Customers and Suppliers.

- Train QC personnel in all aspects of Quality.

1998 - 2000 Quality Engineer, Precision Resource Canada, Cambridge, Canada

- Prepare PPAP submissions.

- Develop FMEAs, Control Plans.

- Train QC personnel.

EDUCATION

2000 Program Management

1998 - 1999 Quality Assurance Program, Conestoga College 1996 - 1997 Environmental Engineering, Conestoga College 1992 - 1996 B.Eng., Engineering, Conestoga College TRAINING

Ford 8D Problem Solving Certified Internal Auditor 5 S Propgram GM 5 Why Microsoft Office Package Mistake Proofing APQP / PPAP / FMEA Core Tools AutoCAD

NADCAP SPC Software – Minitab Geometric Dimensioning &Tolerancing

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