Kim Niles

Current

Sr. Quality Engineer at Quidel
Fellow & Officer at American Society for Quality
Consultant at BPS for Lean Six Sigma

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Past

Quality & Statistical Consultant at NuVasive
Sr.QE at Alphatec Spine, Inc.
Quality Manager at Delta Design, Inc

Supplier Quality Engineer at Alaris Medical Systems
Process Engineer at Tactyl
Quality, Cost, & Delivery Supervisor at Casio Electronics
Application Engineer; Research Scientist at Deposition Technologies
Sr. Research Technician at Biomagnetic Technologies, Inc.

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5 more...

Education

California State University-Dominguez Hills
San Diego State University-California State University

Recommended

11 people have recommended Kim

Connections

311 connections

Industry

Management Consulting

Websites

Kim Niles’s Summary

Certified Lean Six Sigma Master Black Belt and Quality professional with a Masters degree (MSQA) and over 22 years experience solving problems, developing new products, establishing standards, leading and managing people, and teaching topics of statistics, influencing people, creating change, and improvement. American Society for Quality Fellow (top award).

Kim Niles’s Specialties:

- Lean Six Sigma Master Black Belt (UCSD 8 classes or 95GB/85BB)
- Statistics & Testing. Statistical s/w fluent. 205+ DOE's
- Certified Quality Engineer (ASQ CQE 12/7/2002 #44182)
- R&D: Axiomatic design, DFX, DFSS, TRIZ
- Standards Impl.: ISO14971,13485,9001:2000;TL16949;AS9100;QS9000
- Medical Device: Class I,II,III; pharmaceutical and biologics
- Writing: 39 Publications for 3 Million circulations
- Speaking: 195Talks; SDSU, UCSD, and NU/ASQ adjunct

Kim Niles’s Experience

Sr. Quality Engineer

Quidel

(Public Company; QDEL; Biotechnology industry)

June 2009 — Present (6 months)

Evaluating and improving operations efficiency, consistency, proficiency, effectiveness, waste (muda, mura, muri), and safety.
Fellow & Officer

American Society for Quality

(Management Consulting industry)

2001 — Present (8 years )

ASQ's highest award. One of ~300 in the world out of ~100,000 members... 3 total in San Diego.
Consultant

BPS for Lean Six Sigma

(Management Consulting industry)

2000 — Present (9 years )

See http://www.bps.net/ .
Quality & Statistical Consultant

NuVasive

(Public Company; NUVA; Medical Devices industry)

December 2008 — June 2009 (7 months)

Near full time Consultant (~.5yr project). Medical implants, biologics, and surgical tools. Managed one efficiency related project for new product development to solve a 3 year old $500K problem.
Sr.QE

Alphatec Spine, Inc.

(Public Company; 501-1000 employees; cohu; Semiconductors industry)

September 2007 — August 2008 (1 year )

Surgical and Medical Instruments and Apparatus. Statistical and quality support for FDA 510K submissions, supply chain improvements, process validations, and up to 10 new product development teams for implant (screws, plates, rods, stints), instrument (surgical tools), and Biological development applications (stem cell, conditioned bone, pastes, packaging, etc.) for both MIS and traditional forms of surgery. One DOE resulted in a discovery that moved development of an aspect of a novel Osteoporotic bone stint ahead by at least three months. Provided statistical support for Stout Medical Group joint venture.
Quality Manager

Delta Design, Inc

(Public Company; 501-1000 employees; cohu; Semiconductors industry)

December 1999 — September 2007 (7 years 10 months)

Quality Eng., Manager. Microchip test handling equipment (~$250MM/yr.; 1300empl.max). Implement statistical techniques & manage numerous special projects to Dev. Quality systems, maintaining ISO, customer audits, internal audits, & Six Sigma. On 3 company purchase transition teams (Unisys, Kryotech, Slumberge). DCCMM data mining and analysis. Cost analysis. Directly supervise to 18, Indirectly to 29. Significantly advanced dot code reading technology and resulted in developing a publication & new product. Braze weld project saved ~$400k/yr. Four projects saved a customer sum total potential loss of ~$400MM/yr. via ESD & braze weld DOE's. Chiller project for ~$2MM from ~90% to 5% reject rates. Internal trainer for Managers and Supervisors on quality tools and statistical techniques. Internal facilitator of numerous Eng.& top management projects for barrier braking (bent lead at $4M). 5x Recipient of the prestigious Intel SCQA/PQS Awards (2000-2006)!
Supplier Quality Engineer

Alaris Medical Systems

(Management Consulting industry)

1998 — 1999 (1 year )

IMED® and IVAC® IV infusion therapy systems, Instromedix® cardiac event recorders and pacemaker follow-up systems, and temperature monitoring equipment manufacturing with two Maquilladoras. Quality for 400+ vendors using quality, process, industrial, and statistical techniques. Successful project (2-DOE's) caught up multi-million piece backlog. Consolidated & edited 180+ part drawings. Wrote ATP's, RIR's, MR's, NCMR's, QIE's, CAR's, SOP's, WI's and SSMF's. Performed numerous audits and vendor certifications.
Process Engineer

Tactyl

(Management Consulting industry)

1996 — 1998 (2 years )

Natural & Synthetic Rubber Gloves, Condoms, Catheters, and Sleep Apnea Masks. Saved ~$2M/yr improving 9yr mature machinery by over 70%. Measured & mitigated significant third order interactions. Assisted in attaining ISO9002 and CE mark (EN46002, MDD93-42-EEC) and related cGMP/QSR compliance and validation efforts. Performed over 60 designed experiments
Quality, Cost, & Delivery Supervisor

Casio Electronics

(Management Consulting industry)

1991 — 1995 (4 years )

Consumer Electronics ($60MM). Responsible for key supplier quality, delivery, and cost. Tijuana Maquiladora produced piano keyboards & pocket TV's. Supervised up to 15 receiving, source, and production QC inspectors. ISO 9002 Project Manager. Process engineering with injection molding (to 1950T), insert injection molding, gas assisted injection molding (GAIN), blow molding (to 20oz), preprint and corrugation, EPS/EPE foam molding, label manuf., electro-galvanizing, & metal stamping (to 900T). Japanese lang. proficiency of 30% , Spanish at 85%.
Application Engineer; Research Scientist

Deposition Technologies

(Management Consulting industry)

1987 — 1990 (3 years )

Thin Film/Coating & Laminating. New products and technical sales support. Responsible for designing and specifying materials/processes utilizing the application of thin films & polymeric coatings through coating/laminating & physical vapor deposition technologies. Skin contact, atmospheric barrier, 1/4 wave multilayer optical designs, susceptor, and piezoelectric films. Developed two joint ventures and five related patents. One of my inventions (patent application) generated $3M/yr. Negotiated $300K with Pillsbury.
Sr. Research Technician

Biomagnetic Technologies, Inc.

(Medical Devices industry)

September 1985 — March 1987 (1 year 7 months)

Manufacturing medical magnetic sensing equipment (Bio/Neuro-magnitometers). Responsible for entire process of manufacturing and testing microchips, probe subassemblies, and final superconducting assemblies from complex blueprints. Achieved an increase in chip yields per wafer of ~75%.

Kim Niles’s Education

California State University-Dominguez Hills

MSQA , Quality Science , 2000 — 2003

Activities and Societies:

Many, see www.KimNiles.com
San Diego State University-California State University

BSIT , Industrial Engineering & Technology , 1980 — 1984

Activities and Societies:

Band; Astronomy