Quality Assurance Engineer

Roy Roper

Email: *********@********.***

Address: ***** *** ***. ****** **

City: Bradenton

State: FL

Zip: 34212

Country: USA

Phone: 941-***-****

Skill Level: Management

Salary Range: 140

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Roy G. Roper

14715 2nd Ave. Cir. NE Bradenton, Florida 34212

941-***-**** (home) 727-***-**** (cell)

e-mail: *********@********.***

SUMMARY:

Experienced Process development and Control professional with background in diversified operations, project management and process improvement, with strong collaborative skills, is seeking an opportunity to use skills and experience to make significant contribution to a strong, growth company in the medical device industry.

CORE BUSINESS COMPETENCIES:

Led Product Assurance, project management efforts developing more efficient processes, manufacturing operations, and solving quality problems using CAPA, negotiating business agreements, establishing and meeting objectives resulting in significant profitability and cost savings.

* Skilled at identifying trends.

Ability to communicate at all organizational levels and across functional groups, both internally and with customers.

CAPA, GMP, Six Sigma Blackbelt, Statistical Process Control (SPC), ISO 9000, TQM, Core Selling Skills, Strategic Development, AIAG proficiencies.

Computer literate. Use MS Office products (WORD, Excel, PowerPoint). Also, Use Minitab and Statgraphics statistical analysis software and Lotus products.

* Skilled supervising and managing a work group of 35 subordinates.

* Develop and manage budgets of $500,000.

Bachelor`s degree and graduate study in Industrial Statistics and Business Administration.

SELECTED PROFESSIONAL ACHIEVEMENTS:

* Collaborated with team of executives from West and a major pharmaceutical customer to develop a partner-style relationship. Used people skills to resolve thorny customer issues. Improved customer relations resulted in additional $15M business.

* Coordinated joint CAPA project between my employer and Bristol Myers Squibb to understand effects of gamma sterilization on customer`s product. Utilized statistical process experimentation to identify critical process parameters. Resultant process changes improved customer`s market share by $2M.

* Lead Six Sigma cross-functional team to successful conclusion of a CAPA project that saved my employer well over $400K annually with a rubber sheeting process. Identified potential savings and used FMEA, Process mapping, Flowcharting, Design of Experiments in understanding problem and developing solutions.

PROFESSIONAL EXPERIENCE

August 2011 to August 2012 TERUMO CARDIOVASCULAR SYSTEMS, Ann Arbor, Michigan

CAPA Engineer II, Contract Position

* Developed Aged CAPA Management program plan.

* Investigate NCR`s and CAPA`s.

* Use statistical tools, Cause-Effect Diagrams, people skills to identify root cause.

* Work with Terumo CAPA owners to develop Corrective and Preventative Actions.

* Mentored CAPA owners in CAPA tools and processes.

August 2010 to March 2011 STRYKER ORTHOPEDICS, Newark, NJ

CAPA Consultant, Contract Position

* Worked with team on CAPA Timeliness Project to eliminate backlog of CAPA`s.

* Used collaborative skills to remove barriers and close CAPA`s.

* Used DMAIC methodology to discover root cause.

* Mentored Stryker CAPA Assignees to assure that adequate information inserted in CAPA files.

* Worked with multi-functional teams to develop Root Cause and Corrective Actions.

* Wrote memos to explain gaps in CAPA investigations/process.

February 2006 to Present DIMENSIONS CONSULTING SERVICES, Ellenton, FL

Principal consultant/Owner.

* Challenged with developing Process Control Systems for customers with various technologies.

o Used extensive Process Control experience to select appropriate tools to develop appropriate Controls resulting in improved profitability and reduced manufacturing costs.

* Used leadership and communication skills to convince clients of value of modern Quality Systems.

o Leveraged experience and knowledge of Statistical Methods and analysis to design modern Statistical Process Control Systems.

* Presented with the challenge of developing rough, inefficient processes.

o Used Design of Experiments and other statistical tools to improve product quality and reduce waste.

* Develop new business opportunities.

October 2008 to July 2010 General Electric Energy, Palmetto, Florida

Quality Engineer

* Developed method of mapping transformer rebuild process.

* Managed Process Quality Reporting system.

* Worked several Six Sigma projects to improve processes.

* Performed workstation audits.

September 2008 to October 2008 Smith & Nephew Wound Management, Largo, FL

Quality Engineer, Contract Position

* Improved summary reporting of NPWT complaints to emphasize causes.

* 30% reduction in open customer complaints.

October 2006 to February 2008 HONEYWELL, INC., Sarasota, FL

Senior Quality Engineer. Contract Position.

* Used people skills and problem-solving skills to resolve quality issues with major customers (i.e., Caterpillar, BRP-Rotax, John Deere, Polaris) resulting in reduced line failures for customers and improved customer satisfaction

* Using knowledge of Quality Systems and standard process control tools, quickly mastered unfamiliar process and made immediate contribution.

* Used technical skills and Quality system experience to provide QA input to Honeywell Engineering on design and quality projects helping to resolve quality issues early in the product life cycle.

* Quickly learned Failure Analysis skills and developed reports leading to effective corrective actions.

* During transition of business from Sarasota, Florida, site to Juarez, Mexico, used people skills and experience in working with customers to resolve customer concerns and accompanied customer on qualification visit to Juarez.

1975 to 2006 WEST PHARMACEUTICAL SERVICES, Lionville, PA

West Pharmaceutical Services is the premier supplier of rubber and plastics components for injectable drugs, biopharmaceuticals, and medical devices and services to the manufacturers of those products.

Six Sigma Engineer/Florida Plants (2002 to 2006)

* Established a Six Sigma program in Florida plants.

* As a Blackbelt knowledgeable in the DMAIC methodology, developed and managed several projects. One project saved employer $400K annually.

* Led validation efforts during equipment transfer from Kinston, NC, plant after plant

explosion.

* Developed validation protocols and led execution team for new rubber mixing process.

Quality Assurance Manager - Clearwater, Florida (1998-2002)

* Managed plant relations with customers by developing and maintaining key customer contacts.

* Developed high level of biopharm, pharmaceutical, and medical device customer confidence in employer`s operations by insuring that cGMP training up-to-date and facility is in compliance, as well as proper interpretation and adherence to process control procedures.

* Responsible for developing budgets, hiring, training, and providing direction for department personnel. Developed budget for $500,000 QA section and supervised 7 subordinates (hourly and professional).

Quality Assurance Manager - St. Petersburg, Florida (1992-1998)

* Managed plant relations with customers by developing key customer contacts.

* Challenged with responsibility to develop professional Quality program for major manufacturing facility.

* Developed Process Control system that generated a high level of confidence from medical device, biopharm, and pharmaceutical customers.

* Developed cGMP training and insuring that facility is in compliance, as well as proper interpretation and adherence to process control procedures.

* Responsible for developing budgets, hiring, training, and providing direction for department personnel. Developed budget for $500,000 QA section and supervised 35 subordinates (hourly and professional).

Process Manager, Quality Assurance (1986-1992)

Corporate staff position.

* Responsible for developing solutions to technical problems with major pharmaceutical customers.

o Used collaborative skills and experience in Statistical Process development to solve major customer technical and GMP issues, such as identifying source of increased carcinogen levels in rubber baby nipples for infant nutritionals.

* Develop process and equipment validation protocols (IQ, OQ, PQ).

* Responsible for improving process control procedures and developing CAPA for major quality issues in domestic plants and Singapore.

o Collaborative problem solving skills and SPC resulted in cost reduction and improved customer relations in Singapore plant. With improved process control, Singapore facility was able to ship to domestic medical device and pharmaceutical customer locations.

* Used collaborative skills to successfully lead cross-functional teams and to develop solutions to major product quality issues in WPS` manufacturing sites.

* Using Statistical tools, consulted with R&D group to develop appropriate process controls for new products and processes, which included plastics injection molding and rubber molded products. This resulted in smoother product introductions.

Quality Assurance Manager - Kinston, NC (1975-1986)

* Managed plant relations with customers by developing key customer contacts.

* Challenged with responsibility to develop professional Quality program for new rubber molding facility, developed Quality and Process Control systems.

* Responsible for developing budgets, hiring, training, and providing direction for department personnel. Developed budget for $500,000 QA section and supervised 35 subordinates (hourly and salaried professional employees).

EDUCATION:

PENNSYLVANIA STATE UNIVERSITY, Great Valley Campus, PA

Graduate study in Industrial Engineering/Industrial Statistics.

AUGUSTA STATE UNIVERSITY, Augusta, GA (Formerly

AUGUSTA COLLEGE)

Awarded BBA/Management.

Attended Graduate School of Business

* CLEMSON UNIVERSITY, Clemson, SC

AFFILIATIONS:

* Senior Member, American Society for Quality. ASQ Certified Quality Engineer (1978-2005).

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