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Manager Quality Assurance

Location:
Greenville, South Carolina, United States
Posted:
October 20, 2016

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Robert Shue

Easley, SC *****

acw5o0@r.postjobfree.com 864-***-**** https://www.linkedin.com/in/robertshue

Technical Business Leader

Business / Leader Partner with expertise in technical, performance, and strategic direction in healthcare, electronics, capital equipment, and military environments. Proven successes domestically and internationally, with the ability to manage multiple locations and remote groups. Recognized as a go-to person building a high-performance team of technical and non-technical personnel. CFII (Certified Flight Instructor Instrument).

Areas of expertise include:

Project Management

Strategic Planning / Execution

Customer Focus

Process Improvement

Technical Training

FDA QSR, GMPs, ISO and Military Standards

SMT and Hybrid Manufacturing

H V Electrolytic Capacitors

ISO 9001, 13485 & 31000

Communications

Lean Six Sigma and CI

Audits and Auditing

PROFESSIONAL EXPERIENCE

ST. JUDE MEDICAL, St. Paul, MN 2004 – 2016

Site Director Quality Assurance, Liberty, SC 2008 – 2016

Led a multi-site, cross functional team to set-up a complete 60K sq.ft. hybrid microcircuit facility. Facility was operational and FDA approved 3 months ahead of schedule.

Provided final inspection and approval of the facility and processes, working with St. Jude Malaysia operation as US quality liaison for the implementation of hybrid manufacturing in Malaysia.

Replaced manual training records system with electronic system which reduced errors from over 40% to near 0%.

Increased efficiency 15% and reduced errors to near 0% by implementing electronic tracking and execution system in the Liberty Capacitor Receiving Inspection department. (SAP)

Implemented a Receiving Inspection department in the Liberty Hybrid facility.

Successfully managed all aspects of Quality Assurance at the Liberty Capacitor site, Liberty Hybrid site and the Scottsdale AZ site simultaneously.

Site Quality Manager / New Product Project Manager, Scottsdale, AZ 2004 – 2008

Led a team to bring in-house and implement new processes to be used to manufacture future generation product at St. Jude Medical. Implemented a SMT manufacturing line along with a BGA manufacturing line. These lines have been duplicated in several facilities to produce the electronics assemblies utilized in ICDs and Pacemakers.

Developed system requirements for an electronic system to track and manage returned product through the rework processes, then formed and led a small team to implement the system. The system increased the efficiency of the rework process by approximately 50% and reduced the turnaround time by 40% while providing accurate traceability information.

Trained production associates, working with Manufacturing, on the quality requirements of what was being built and reduced four 100% inspection steps to random audit inspections, reducing inspection times by 80%.

Robert Shue https://www.linkedin.com/in/robertshue Page 2 of 2

HEI INC., Victoria, MN 1999 – 2003

Director of Engineering and Quality Assurance

Reduced project time by 45% and development costs by 50% by combining all engineering functions to form an efficient team.

Developed proposal for, justified to the board of directors then implemented an advanced development group.

Improved prototype on-time completion from 40% to over 90%.

Created a Broadband development team to execute a new strategy for HEI. Team was issued several patents and produced a number of broadband parts utilizing the patents.

Personally led HEI in an upgrade of the quality system to successfully obtain ISO 9000 / 2000 certification. This involved a complete rewrite of the quality documents.

SULZER INTERMEDICS INC., Pacemakers Division, Angleton, TX 1990 – 1999

Quality Assurance Manager / Senior Manager Hybrid Technology Research Center

Created, staffed and ran the Hybrid Technology Research Center.

Led a major upgrade of Intermedics’ process validation system. FDA used it as an example.

Implemented a “Build it Right the First Time” program at Intermedics resulting in a reduction of inspection from 100% to a sample basis.

Instituted the use of DOE, SPC, FMEA's and formal problem solving techniques at Intermedics.

Prior to 1990 worked at Siemens Hearing Instruments Inc., Piscataway, NJ, Omnitek Inc., Trevose, PA and Kulicke and Soffa Industries Inc., Willow Grove, PA

EDUCATION / AFFILIATIONS

Associate’s Degree in E.E. equivalent, Air Force Electronics School, Aurora, CO

Six Sigma Green Belt Course (St. Jude Medical)

Product Management Course I And II (Drexel University)

Darden School of Business Leadership

Marketing Management Skills Workshop (Rutgers University)

Effective Negotiating (Center for Effective Negotiating)

Problem Solving and Decision Making Course (K & S)

Train the Trainer (American Management Associations)

Various Seminars and classes on Mil Specs, Technical Processes, Process Validation and FDA QSR

ASQ (American Society for Quality) Member

IMAPS fka ISHM (International Microelectronics And Packaging Society)

Served on the ISHM committee that worked towards Hybrid Factory Automation

PUBLICATIONS

Written and presented numerous papers on semiconductor applications and automation at several conferences including:

ISHM (International Society for Hybrid Microelectronics) (now IMAPS)

SEMICON, IEEE

MTAG (Manufacturing Technology Advancement Group) Military

US Trade center in Brazil

“Introduction to Ball Bonding of Semiconductor Devices" Connection Technology



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