Chris Idzerda Email and Phone Number

Making custom soaps: lye soap lavender soap oatmeal vanilla soap, orange turmeric soap. Custom orders 4 week lead time. More info Tenmilecreeksoap@gmail.com

Performing component qualification using robust statistics at a recently acquired company. Identifying cost savings opportunities: $715,000 in 18 months.Core team member on major projects: new printing software, registar change.

Driving the reduction in warranty claims using Six Sigma methodology. First project will address current out of box failures for db level of alarm on Class I medical device. Final project was the complex issue of 80% failures in production with no response from suppliers: data data data + the customer stepped in to push the process along.

Working with suppliers to assure qualifications have been performed to meet the requirements of ISO13485 and 21 CFR Part 820.

Driving projects to reduce warranty failures using Lean Six Sigma Tools. First year in position save $205,000 on one project.Currently working two projects to save at least $160,000.Launching data driven diagnostics of diesel engines in Dyno. 2nd year with company I saved the company a little over $500,000.Training Quality Technicians the appropriate use of statistics.In third year savings are now cruising along to achieve $800,000.

Lead Validation teamsAuthor validation plansAuthor validation reports ensuring use oh robust statistical methods

Lead analysis of field failures developing 8D reports for customers. Drive continuous improvement using MSA and Lean Six Sigma tools.Using statistics added controls to process to improve product quality.

Senior Quality Engineer driving Continuous Improvement using Lean Six Sigma tool set. Mentor others in Lean Six Sigma tools to help improve all processes.

Analyze and complete detailed process mapping of CAPA and CAPA sub-systems. This includes Supplier Quality issues, Manufacturing Nonconformances, Product Complaints, and Audit reports.

Prepare validation reports for all process changes. Team member launch of Lean ManufacturingMaintain compliance with ISO13485Prepare supplier control plans for purchased products.

Lead teams using Lean Six Sigma tools to improve quality and productivitySavings first year $1.3 MillionSavings 2nd year targeted at $2.7 millionTrained 16 Six Sigma Green BeltsTraining 37 Managers and Supervisors in Fundamentals of Lean Six SigmaLead Lean Kaizen Event with savings of $170,000.

2003 to 2008) Saved more than $9 million per year in 2007 by successfully mentoring 20 Green Belt, Black Belt and Lean Manufacturing projects.Certified 11 Six Sigma Green Belts, 3 Six Sigma Black Belts, and 4 Lean Manufacturing candidates in 2006/2007.Implemented SPC in plant reducing waste and improving Cpk from 1.3 to 4.5.Saved $55K per year by reducing waste in the product sterilization processAvoided FDA 483 by validated USP Purified water system that eliminated manual testing for conformance. Saved $50,000 by eliminating 2 days of WIP in contract Gamma Sterilization by improving communication flow.Saved $165,000 by 3% change in thread content of gauze product.Saved $68,000 by implementing process supermarket / kanban systemISO 13485 Lead AuditorTaught 20 Six Sigma Green BeltsTaught a 2.5 day Six Sigma / Lean overview course to 25 managers at; plants.Taught a 1 hour Muda and Kaizen concepts course to 450 people at; plant.

Saved $125K per year by reducing labor and scrap in the manufacture of 7200 Flow Sensors. Saved $90K per year by enabling transfer of product from outside supplier to in house.Improved customer satisfaction by eliminating customer complaint on 7200 Compressor.Eliminated ergonomic back injury risk by demonstrating process step was Muda.Eliminated back order on key ventilator pneumatic valve by reducing calibration time from 3 hours to 15 minutes.Led team to find and validate new silicone material for 700 series exhalation valve- support sister plant production.Mentored Green Belt candidate to certification -50% cycle time reduction in processing product paperworkImproved Ppk from .8 to 2.6 on exhalation valve.Lead ISO 9000 internal auditorSuccessfully migrated plant from ISO 9001 to ISO 9002 certification without non-conformances. Validation Engineer for all new product introductions: IQ/OQ/PQ.Resolved customer complaints for portable ventilator products.Primary FDA contact for portable ventilator products.

Developed curriculum and taught 12, 10 week classes in statistics for business and economics.Taught 12, 10 week classes in Microsoft Excel.