CURRICULUM VITAE

 

R. Stephen Kuykendall

2283 Colt Drive

Saratoga Springs, Utah 84045

801-331-8339 (h)

801-472-0315 (c)

Professional Experience:

 

Corporate Vice President of Quality Systems8/11 – Current

Merit Medical Systems, Inc.South Jordan, Utah

 

Report to Chief Operating Officer.  Serve as the Corporate Officer over Quality Systems.  Scope of responsibilities includes management responsibility for all aspects of the quality systems in Utah facilities (South Jordan, West Jordan and Murray), as well as corporate oversight for worldwide Merit facilities, including Virginia, Texas, Massachusetts, Ireland, France, Netherlands, China, and etc. 

 

Director of Quality Assurance - Compliance4/10 – 8/11

Merit Medical ServicesSouth Jordan, Utah

 

Report to VP of Quality Assurance.  Scope of responsibilities includes management of quality systems in support of commercial operations.  Examples of management responsibilities include:

·               Risk Management

·               Internal auditing

·               OEM, ISO and FDA audit hosting

·               Complaints - MDR and Vigilance reporting

·               Supplier Management

·               Software Validations

·               CAPA systems

·               Calibrations

 

 

Director of Quality Assurance2/08 – 02/10

Watson Laboratories, Salt Lake City, UtahSalt Lake City, Utah

 

Report to the Executive Director of Quality Operations. Scope of responsibilities includes management of quality systems in support of both commercial and development. Examples of management responsibilities include:

 

·                           Management of In-Process and Incoming Quality Assurance departments and Quality Assurance Documentation

·                           Auditing of manufacturing processes

·                           Manage the Supplier Management Team

o      Risk evaluation and recommendations related to poor supplier ratings

o      Quality investigations – Deviations and CAPA’s

·                           Manage the release of products

o      Quarantine and control of nonconforming products and materials

o      MRB and Supplier CAPA

·               Manage quality documentation and change control process

·               Liaison with marketing partners

o        Investigating product complaints

o        Communicating change control

·                           Develop and implement policies and procedures

·                           Hiring and salary negotiations

·                           Performance management

·                           Manage efficiency improvements, KPI’s, trending, and Right the First Time initiative

·                           Report on quality systems in quarterly management review

 

 

Director of Quality Assurance and Regulatory Affairs    7/05 – 2/08

MEDRON Inc. 1518 S. Gladiola St, SLC, Utah (8/05 – 2/08)  Salt Lake City, Utah

 

Was hired in July of 2005 to help MEDRON obtain 13485:2003 certification and to improve the company’s quality system after a 2004 Warning Letter from FDA.  MEDRON is an OEM manufacturer of medical devices.  Activities included:

 

·                          Developed and Implemented an effective management review system

·                           Wrote an effective Quality Manual

·                           Revised all key procedures and policies

·                           Developed an effective complaint evaluation system (turnaround average = 20 days)

·                           Developed an effective CAPA System (turnaround average = 20 days)

 

·               Developed and implemented an effective Internal Audit System (turnaround average = 20 days), obtained certification for four ISO 13485:2003 internal auditors

·                           Established internal auditor training program

·                           Obtained certification for five auditors

·               Developed an effective Management Review System with monthly Quality Systems Reviews and semi-annual Management Review meetings

·                           Established company quality objectives with trending of quality performance indicators

·                           Member of development team

·               Served as Management Representative

·               Hosted all FDA and ISO inspections/audits

 

In March of 2006 certification to 13485:2003 was achieved with zero non-conformances and with commendations from KEMA (notified body)…  Hosted three ISO audits and numerous customer audits…

As a result of a follow up audit and numerous correspondences the company received a letter that stated “FDA considers the issue of the Warning Letter Closed.” 

Note:  This position was sought and accepted when a transfer back to Utah was not possible at Fresenius Medical Care after three years service in Mexico.  MEDRON was recommended as a good employer by management at Bard Access Systems, since MEDRON manufactures most of the CV and PICC catheters for Bard as an OEM supplier.  Bard management recommended me to MEDRON to assist them in taking their quality systems to the next level.

 

Site Head of Quality Systems    12/02 – 7/05

FRESENIUS MEDICAL CARE (7/99 – 7/05)  Reynosa, Mexico

 

Promoted to the head of quality in December of 2002, I reported to the corporate VP of Quality in Boston, MA.  Responsibilities included plant oversight, management and direction of all quality systems and compliance related activities in the Fresenius Medical Care Plant, a 2500 employee medical device manufacturing facility located in Reynosa, Mexico. FMC is the world’s leading supplier of dialysis products and clinical services.  Responsibilities and Accomplishments included:

·               The position included directing all plant activities as they related to quality assurance and compliance, including Quality Engineering, Compliance (Internal audits, CAPA, ISO), Laboratory and Technical Services, Documentation Systems, Complaint Evaluation, Supplier Quality Assurance, and Quality Assurance in three internal manufacturing factories (Plastics, PD Mfg, BL Mfg).

·                           Developed an efficient Quality Engineering team with 6 Sigma brown and black belts

o    Created cell teams with QE and Manufacturing Engineers focused on process improvement

o    Created an effective complaint evaluation team with feedback to design and improvement

·               Developed a FIFO project for evaluating product improvements.  A select distribution process funneled the first production lots after corrective actions or improvements immediately to clinics to evaluate effectiveness.

o            This process reduced product complaints from 80+ ppm to less than 10 ppm (Six Sigma Quality) while manufacturing increased by over 40% during the 3 year period.

Other successes included

o           Developed and validated a parametric release program for the accelerated release of sterilized products;

o           Managed the transition to ISO 13485:2003

o           Developed a Cost of Quality Program with reporting in monthly reports and quarterly mgmt review

o           Developed an effective Risk Analysis program based on FMEA – both design and process

o         Created a “Get It Right the First Time” program in manufacturing that focused on evaluating errors and creating effective preventive actions  with a systemic approach to eliminate similar errors in the future.

o         Developed an effective communications system between the plant and Corporate to emphasize accomplishments in quarterly management review meetings 

·                           Responsible for hosting FDA and ISO inspections/audits

 

 

Senior Quality Engineering Manager7/99 - 12/02

FRESENIUS MEDICAL CARE (7/99 – 7/05)     Ogden, Utah

Hired in July, 1999 as Sr. QE Mgr, Responsibilities included management of the departments of Sterilization Validation (gamma, e-beam, EtO, and steam systems for both devices and drugs), Metrology, Complaint Evaluation, and Quality Engineering.  Responsibilities included overseeing QA responsibilities for both the device and drug production processes.  The Ogden plant is one of the largest medical device and Peritoneal Dialysis solutions manufacturing companies in the US, and is one of the largest medical device manufacturers in Utah.  Responsibilities and accomplishments were as follows:

·               Development and implementation of statistical programs of data analysis and Design of Experiments in the manufacturing process;

·               Co-hosted FDA Inspections for both the device and drug manufacturing plants. 

·               Project Manager – design improvement projects – Received patent for design improvement of the FMC dialyzer housing

·               Transfer of manufacturing product lines from Ogden, Utah, to Reynosa, Mexico;

·               Served as team leader in coordinating cross-functional teams, including a customer response team that focuses on visiting dialysis clinics to solve product problems and obtain improvement feedback.

 

 

Senior Quality Assurance Manager2/97-7/99

Innerdyne, IncSalt Lake City, Utah

 

Managed Quality Engineering and Quality Assurance departments, including product development, in process and incoming inspection, and validation...

 

·               Developed cross-functional teams targeted on scrap reduction in the manufacturing processes, and served on design development teams. 

o             The scrap team reduced scrap rates to the lowest level in the history of the company by using statistically designed experiments and scientific analysis. 

o             Set up process controls, inspection plans and test methods for testing raw materials and components at incoming, and products in the manufacturing process. 

o             Served as the project leader on new product cross-functional development teams.  The team was successful in developing a new laparoscopic access device that was considered a great improvement in the medical community

o             Co-hosted FDA Inspections and ISO audits

The company was purchased by Tyco in 1999 and all manufacturing processes transferred to outside Utah.

 

Quality Assurance / Field Assurance Manager1993-97

Bard Access Systems (1/92  - 2/97)Salt Lake City, Utah

 

As Field Assurance Manager, responsibilities included the development of an engineering based complaint evaluation department (RGA) at the BAS plant in Salt Lake City, at Gesco (San Antonio), and VasCath (Toronto). 

·               Transferred the complaint and clinical support division from corporate offices in Murray Hills, NJ, to Salt Lake City.

·               Supervision included clinical and legal support groups, as well as maintaining the toll free complaint hotline and field assurance personnel. 

·               Testified in numerous legal proceedings and litigation trials as a witness with success, and coordinated the litigation responsibilities of the division with CR Bard legal division. 

·               Supervision included customer service, clinical nurses, quality engineers, and complaint technicians.

 

As Quality Assurance Manager, responsibilities included assisting in the development of quality systems in the leading manufacturing facility for CR Bard. 

             

·               Responsibilities included the development and management of quality systems in the Salt Lake Plant,

·               Responsible for developing Bard Quality Systems in two acquisitions; Gesco Corp (San Antonio) and VasCath (Toronto). 

·               Served on product design teams

·               Responsible for supplier management, including developing supplier partnerships with key vendors

·               Managed incoming and in-process QA inspection departments

 

Senior Quality Engineer1/1992-93

Bard Access Systems (1/92 - 2/97)Salt Lake City, Utah

 

·               As QE team leader was responsible for the qualification of the Davis Standard Extruder and the development of silicone extrusion technology at BAS through the use of statistical designed experimentation and scientific analysis   

·               Responsibilities included serving as team leader on product design and development teams, supplier management, and manufacturing support 

·               Responsible for complaint evaluations and feedback into the design improvement system

·               Was responsible to solve quality issues for products manufactured in Toronto, San Antonio, and Las Piedras, Puerto Rico with frequent travel to those locations

·               Worked with accounting department and manufacturing to set up the Cost of Quality program for the division,

·               Developed a Supplier Management Program, and coordinated the development of control charts and other process control techniques in the manufacturing processes

·               Led the corrective action follow-up for several FDA and corporate audits, and assisted in controlling and providing corrective action on several product recalls. 

 

Quality Engineering Manager1991

BANTA corporation - Bushman Press - PROVO, UTAHProvo, Utah

 

Developed a specialized team of quality engineers to solve manufacturing process problems, facilitate employee involvement teams, and developed a certification program for operators, including full curriculum programs for each position.  Conducted statistical designed experiment studies of the printing processes, including developing a comparative study and rating system for various types and brands of printing paper. 

 

Quality Assurance Manager - Production Manager1990-1991

Dynix, Inc - Retro LinkProvo, Utah

 

Developed all quality systems and set up a team approach to production.  Created cross-functional teams from the previous three departments and developed an intensive training and employee recognition program.  Production levels were increased by over 300% and the level of first-run quality was improved from 70% to over 95%.  

 

 

Brigham Young University - Student Employment1987-1989

Provo, Utah

 

Research Assistant – Managed the Statistics Help Lab - Professor’s Assistant - Worked while completing degree in Statistics - Quality Science

 

(Note:  Prior to manufacturing I worked for over thirteen years in business and public service unrelated directly to the quality field.  Information on that period is available upon request.)

 

 

EDUCATION

 

Bachelor of Science1986-1989

Brigham Young UniversityProvo, Utah

 

Major:Applied Statistics – with emphasis in Engineering / Quality Science

 

Activities: During this period, worked as a teaching assistant and ran a statistics lab for entry level statistics students.  Co-authored a paper that was required reading for statistics students - The Scientific Method (w/ Professor Dennis Tolley).

 

Associate of Mortuary Science1971-72

Cyprus College (formerly California College of Mortuary Science)Cyprus, California

 

Major:Mortuary Science

 

Activities: Completed a curriculum of pathology, microbiology, chemistry and business.  Was valedictorian of graduating class; was awarded the Mu Sigma Alpha award for excellence; and passed both the National Board and Arizona Board examinations.

 

 

 

     PROFESSIONAL

 

·               Salt Lake Section Chair - American Society for Quality (ASQ): 1992-93 - Started the section scholarship program.  Accomplishments of the division – Co-founded the Utah Quality Award.  Currently a Senior Member.

·               Salt Lake Section - ASQ: 1992, 1994 - Symposium Chair - organized and chaired quality symposiums with speakers from various quality disciplines

·               Salt Lake Section Newsletter Editor: 1990-92, 1996-98 - wrote and published the monthly newsletter for ASQ.

·               Presenter at multiple Quality Symposiums in Salt Lake City and Ogden, Utah, on Statistical Methods and FMEA

·               Community College Instructor 1978 - 1986

·               Received a patent for a design change to the FMC Dialyzer (US Patent # 6,802,821)

·               Authored several articles published in national syndicated magazines

·               Co managed Quality Science Consulting with two fellow statisticians.  Provided training in the areas of FMEA, Manufacturing Statistics, and Supplier Management.