WALTER L. SANDERS

262-***-**** Cell

accjhg@r.postjobfree.com

SUMMARY

- Quality professional with experience in the design, development and

implementation of complete Quality systems

- Extensive background in Quality Engineering, Customer

interface, Supplier Quality, Process Quality, Quality Systems

Assessment, and Quality Assurance (e.g. Reliability engineering for

power supply systems, metal fabrication and finishing, Supplier

development via audits and effective CAPAs measured by the stages and

final use of the products.)

- Managed the initial processing, and final approval of

validations.

- Demonstrated success and extensive experience in problem

identification and resolution, organized and reliable

- Designed Quality Development Lab and Quality Assurance Lab for support

of manufacturing and production.

- Purchased, set-up, inspection equipment (CMM, Vision systems, standard

inspection equipment and product specific designed gages, etc.)

EXPERIENCE

2011 - 2012, Plant Quality Engineer, MIRA Inc, Uxbridge MA

. Team member in the activities successfully reacquiring the ISO 13485

certification.

. Member of Risk Analysis Team

. Team member in the recertification FDA license. (awaiting FDA audit visit

at my day of my separation)

. Managed the revival and recertification of the "White Room" operated in a

"Cleanroom" mode.

. Performed activities to improve the quality systems via sops, quality

tools, training, etc

. Preformed the review and signoff of Device Master Record or the Device

History Record

2010 - 2010, Senior Quality Engineer, Accellent Inc, Brimfield

. Managed Customer Complaint processing from receipt thru problem

resolution.

. Worked directly with suppliers to resolve product quality issues through

process improvement

. Lead Auditor

2008 - 2009, Quality Manager, Miniature Tool and Die, Charlton, MA

* Manufacturer of custom miniature injection molded components for the

medical industry

* Major supplier for CR Bard, previous position.

* Retained as their first Quality Manager

* Responsibilities include the continued development of critical medical

components

* Restructured quality systems to comply with the requirements of ISO 13485

. Ensure that all quality standards are adhered to in support of

production and customer needs.

. Management Representative for ISO 9001:2001

. Managed corrective and preventive action systems as part of PFMEA.

(Presentations provided to DFMEA)

. Worked directly with Customers

. Worked with the President and Engineering in the process development

of validation quality activities.

. Managed the certification of 2 Cleanrooms and 1 laboratory to Class 8

(100k) with microbial monitoring.

2008 - 2008, Contract Senior Quality Engineer, Aries Group, Inc. Beverly,

MA

* 6 month contract with Davol, Warwick, RI (Division of C.R.Bard) a

Manufacturer of medical devices

* Worked independently as an onsite Senior Quality Engineer with major

supplier of miniature injection molded components

* Responsibilities included quality system assessments, quality system

development to support production of medical components

* Systems developed were designed to comply with ISO 13485:2003

* Provided weekly progress reports of program's development

* Ensure plans for critical dimensions, control plans, process flow

diagrams, SPC plans, FMEA's, measurement systems, validation protocols

(IQ/OQ/PQ), etc. are compliant to the requirements of CR Bard. Authored

the required documentation.

* Worked directly with CR Bard program team consisting of quality

engineering, manufacturing engineering, purchasing and design.

* Completed assignment and began employment at Miniature Tool and Die.

2006 - 2007, Quality Manager, REXAM PHARMA, Wheeling/Buffalo Grove, IL

. Manufacturer of custom injection molded components for medical

industry.

. Responsibilities include identifying and resolving systemic quality

problems, maintaining and enhancing plant level quality system reporting

performance metrics

. Instrumental in facilitating the execution of a customer complaint

reduction program. Goal: Reduce customer complaints 30% per year for next

3 yrs.

. Ensure that all quality standards are adhered to in support of

production and customer needs.

. Assured quality systems were in compliance with regulatory agencies

. Management Representative for ISO 9001:2001 and ISO 13485:2003

. Managed corrective and preventive action systems.

. Worked directly with Program Managers, Customers and Suppliers.

. Directed all process development/validation quality activities.

. Provided quality performance presentations monthly, quarterly and

yearly

. Member of process improvement and cost reduction teams

. Key team member for the transfer of plant operations to a new modern

facility with the responsibility of assuring the quality systems were

improved upon and exceeded ISO and customer requirements during and after

the transfer. "Measurement of this success was clearly exhibited by the

results of the numerous re-certification audits conducted by our

customers and the ISO 9001:2001 and 13485:2003 re-certifications. All

were successful.", John Ruhl, U.S. Quality Manager, Rexam Pharma.

. Managed the certification of a Class 8 (100k) Cleanroom from design

through certification.

2005 - 2006, Product/System Quality Analyst, SOLOSYSTEMS GROUP, Milwaukee

WI

. Design and develop technical training programs

. Product development for new products

. Quality and technical analyst for product/program development

1998 - 2005, Quality Assurance Manager, PM PLASTICS CO. Pewaukee, WI

. Contract manufacturer of injection molded plastic products such as

toys, housewares, and advertising displays

. Direct quality program development and implementation to comply with

major Point -of-Purchase customer's requirements

. Major responsibilities were to access the present business practices,

develop a quality program to facilitate the introduction of multi-part

and multi-assemblies program in addition to implementing preventive and

quality improvement plans

. Central focus for all process capability studies, PPAP, control

plans, DOE, Gauge design and validation, etc.

. Other responsibilities included the design and implementation of

effective quality systems within the main and annex facilities

. Multi-part and multi-assemblies program yielded over 10 millions

parts with a quality rating of 99.99%; Program used as a base for ISO

introduction to plant

. Developed and implemented Quality Training Program for all employees,

including metrology techniques

. Developed and implemented color inspection technique and training

program

. Expanded quality program to all customers

1996-1998, Director of Quality Assurance, PLASTIC MOLDED CONCEPTS, Inc..

Eagle, WI)

. Company produces custom plastic injection molded products such as

caps and filters for various industries

. Analyze Quality Systems. Develop and implement Quality Improvement

Plan

. Keys responsibilities were to develop the quality systems to bring

continuity in the manner in which employees executed their jobs. Edit and

re-write standard operating procedures to assure departmental and

individual interdependencies are understood, defining responsibilities

and expectations; Significant increase in plant wide quality awareness

. 30 % lower scrap rate

. Increased quality personnel capabilities through training (i.e.

Inspection techniques, calibration, decision making, defect prevention,

time management)

. Increased tool qualification and product analysis capabilities with

the purchase of DDC CMM

1993-1996, Quality Assurance Manager, NYPRO CHICAGO INC. Gurnee, IL

. Member of new custom injection molding plant start-up team

. Designed, developed and implemented the Quality Assurance Systems

Programs.

. Designed and furnished metrology and quality labs

. Manage and maintained 100,000 Class clean room.

. Quality engineering interface for new customer reviewing requirements

to ensure accuracy and manufacturability

. Facilitated all customer certification/re-certification audits

. Trained quality personnel in Quality concepts, principles of

teamwork, SPC, Taguchi, metrology techniques and gage design

. Successfully handled major Fortune 500 companies in the health

and pharmaceutical as well as in the electronic and telecommunications

areas." Peter B. Marshall Nypro Corporate Executive Assistant to the

President and Corporate Director, External Affairs

1991-1993, Quality Engineer, NYPRO INC. Clinton, MA

. Design and directed qualification experiments for Process Development

for mold/assembly qualifications from design concept through production

start-up.

. Developed APQP, PPAP, ISIR, STD and customer specific control plans,

DOE, Gauge design and validation

. Additional responsibilities included gage design, development and

implementation activities

1975-1990, Senior Quality Engineer, DIGITAL EQUIPMENT CORPORATION, Maynard,

MA

. Resolved system, process and product reliability problems in the

manufacturing of monitors and power systems in new product development

and mass production; Efforts consistently resulted in reduced

manufacturing costs and increased product quality and reliability

. Uncovered 15% component failure rate. Coordinated the failure

analysis and corrective action decreasing Failure rate >1%.

Vendor Quality Engineer

. Implemented vendor certification program. Accomplishments resulted in

achieving and exceeding plant quality goals

. Managed 30 - 50 supplier base.

. Directed and developed 8 vendors providing lot yields at 52% average;

Designed and implemented a Quality Improvement Plan which increased lot

yield to 81% in less than within 7 months

. Directed Statistical Quality Assurance program for vendors.

Succeeded in trimming the inspection costs by $3K/month

Manufacturing Quality Planner

. Provided quality engineering support and direction to all

manufacturing departments; Developed and implemented quality improvement

plans. Devised cost reduction measures. Analyzed discrepancies between

company's and vendor's corrective action programs and performance

standards.

. Directed Process Capability Study program for two disk drive systems

to clone manufacturing process; Developed and implemented process

improvement plan with recommendations increasing process yield by 22%

. Researched and evaluated costly production inspection. Established

and implemented quality improvement plan resulting in a $100K per year

savings

CERTIFICATIONS

. American Society for Quality Control Certified Mechanical Technician;

Certification #T-588

. American Society for Quality Control Certified Quality Engineer;

Certification #E11655

. Digital Equipment Corporation, Engineering Review Board Certified

1986

EDUCATION AND TRAINING

. Completed 2 yrs toward a BS. Courses taken:

. Electronics and Graphics for Electronics

. Physics and Calculus

. Introduction to Reliability

. Practical Reliability Engineering

. Theory and Practice of Reliable System Design

. Quality Engineering/Statistics

. Introduction to Statistical Process control/Advance Statistical

Process control

. Quality Function Deployment (QFD) - Designing for Customer

Satisfaction

. Design and Analysis of Burn-in Procedures

. Design for Reliability

. Engineering for Quality by Design, Taguchi method

. Design and Manufacture at Six Sigma (2 week course)

. Mini-Tab

. cGMP and GMP

. Corrective Action

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