Quality Engineer Brigham Young

CURRICULUM VITAE

R. Stephen Kuykendall

** * *** *

801-***-**** (c)

email – ************@*****.***

Professional Experience:

Twenty-eight years in the medical device and pharmaceutical industries

Experienced in

oQuality Leadership

oRegulatory Compliance

oDesign Assurance

oSupplier Management

oStatistical Training and Application

oPost Market Vigilance / MDR / Vigilance

oRisk Analysis and applications

oQuality Systems Development

oTechnical writing

oPreparing for and managing ISO audits and FDA Inspections

oStatistical problem solving and trending (DOE, ANOVA, etc.)

oQuality Auditing (Certified ISO 13485 auditor)

Global Director of Quality and Regulatory 8/1/2020 – 5/31/2022

ATL Technology Springville, Utah

Responsible for corporate quality and regulatory systems globally, including US, Costa Rica, and Dong Guan, China

Reported to the Global VP of Operations. Developed and revised the QMS and helped in the transition from a medical device contract manufacturer to a registered FDA/ISO medical device manufacturer. Directed quality issues and worked directly with customers in providing communications relating to quality. Coordinated with FDA and ISO 13485 (BSI) to host inspections and audits to maintain certifications and registration.

Quality Systems Consultant 2/1/2018 – 7/31/2020

ALKU Consulting – Currently J&J/Ethicon Megadyne – Draper, Utah

Lifecycle Quality Engineer

6/1/18 – Lifecycle Quality Engineering consultant – Transitioning a recent Ethicon purchase (Megadyne) into J&J Ethicon systems – Supporting local team to meet GUDID requirements for reusable products – laser marking, etc., provide support on multiple validation projects, corrective actions issues, providing support for PQSS-DRB meetings, supporting design changes on existing devices. Rewriting statistical procedures and quality applications.

2/1/18 – 5/31/18 EU MDR Readiness Team for MDR Vigilance for Ethicon/CSS – Converting current complaint / lifecycle process over to meet the new European requirements due in 2019.

Caregiver

6/17 – 5/18 Provided care for ailing wife. She passed away in April 2018

Senior Director of Quality Systems 12/14 – 5/17

AngioDynamics, Inc. Glens Falls, NY

Reported to VP of QA/RA. Scope of responsibilities included management responsibility for all aspects of the quality systems in New York facilities (Glens Falls and Queensbury), and worldwide AngioDynamics facilities, including Manchester, GA; Boston, MA; and Denmead, UK. (Quality Assurance, Compliance, Supplier Management, Post Market Vigilance, Compliance, etc.) Drove improvements to eliminate 3 Warning Letters and managed seven FDA inspections and ten ISO audits with minor observations in 24 months. Dealt directly with critical suppliers to solve quality issues. Developed a site quality scorecard to provide direction to site quality managers.

Director of Quality and Compliance 7/14 – 12/14

Pharmatech Labs Lindon, Utah

July – December 2014

Managed the quality system, including inspection, laboratory and audits. Was hired to revise the quality and operations systems to obtain NSF Certification. The overall process took 4 months and Pharmatech Labs was authorized to add the NSF certification label on all products produced in the facility. This signified the facility to be a GMP facility.

Corporate Vice President of Quality Systems 8/11 – 6/14

Merit Medical Systems, Inc. South Jordan, Utah

Reported to Chief Operating Officer. Scope of responsibilities included 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 Pennsylvania, Virginia, Texas, Massachusetts, Ireland, France, Netherlands, China, and etc. (Quality Assurance, Supplier and Risk Management, Post Market Vigilance, Compliance, etc.) Responsible for oversight of all FDA inspections and ISO audits. Developed an QA audit system and provided corporate wide training in statistical applications.

Director of Quality Assurance - Compliance 4/10 – 8/11

Merit Medical Services South Jordan, Utah

Reported to VP of Quality Assurance. Scope of responsibilities included management of quality systems in support of commercial operations. Primary focus was directing quality engineering activities and driving improvement through effective corrective and preventive actions.

Director of Quality Assurance 2/08 – 02/10

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

Pharmaceutical

Reported to the Executive Director of Quality Operations. Scope of responsibilities included management of quality systems in support of both commercial and development. Examples of management responsibilities included the management of In-Process and Incoming Quality Assurance departments and Quality Assurance Documentation, auditing of manufacturing processes, supplier management, incoming inspection, document review and product release, developed and implemented policies and procedures, supplier management, etc.

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

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. Developed and Implemented an effective management review system, i.e., revised all QMS documents, i.e., QM and all key quality procedures and policies, internal audit program (obtained ISO audit certification for 5 auditors), Post market vigilance system, CAPA, and etc. Hosted all ISO and FDA inspections. Developed an effective complaint evaluation system (turnaround average < 20 days). Obtained warning letter clearance from FDA. Provided design assurance in the development process.

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. 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, Peritoneal Dialysis and Blood Line Mfg).

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

•Provided statistical training and taught classes in DOE and process control.

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

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

•Provided design assurance input on all development projects.

•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.

•Hosted FDA and ISO inspections/audits

Senior Quality Engineering Manager 7/99 - 12/02

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

Medical Device and Pharmaceutical

Hired in July 1999 as Sr. Quality Engineering Manager. 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;

•Managed quality and micro responsibilities in production of peritoneal dialysis solutions;

•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 Manager 2/97-7/99

INNERDYNE, INC Salt 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.

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

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

•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

•Co-hosted FDA Inspections and ISO audits

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

Quality Assurance / Field Assurance Manager 1993-97

BARD ACCESS SYSTEMS (1/92 - 2/97) Salt Lake City, Utah

Field Assurance Manager (Post Market Vigilance) 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.

•Developed a product complaint investigation training program that identified the steps in proper investigation of returned complaint product, proper reporting and appropriate response letters to customers.

•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 Engineer 1/1992-93

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. Implemented a DOE approach to optimize all catheter product types

•Responsibilities include 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

•Responsible for coordinating quality systems transfers from Toronto to Salt Lake City after the Vascath acquisition

Quality Engineering Manager 1991

BANTA CORPORATION - BUSHMAN PRESS - PROVO, UTAH Provo, 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 Manager 1990-1991

DYNIX, INC - RETRO LINK Provo, 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%.

EDUCATION

Bachelor of Science 1986-1989

BRIGHAM YOUNG UNIVERSITY PROVO, 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).

PROFESSIONAL

•Certified ISO13485 Auditor

•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

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

VOLUNTEER

Boy Scouts of America – Scoutmaster and Committee Chair for local BSA troops – 15 years

NCAA Track and Field Official – Volunteer as an official for high school and university track & field meets – 10 years

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