MICHAEL P.

BRIMMER
Seattle, WA 98103 www.linkedin.com/in/michaelbrimmer/

206.228.0715
Six Sigma Certified Lean Six Sigma Green and Black Belt Lead Auditor Certified Lead Auditor in ISO 13485/9001 SUMMARY

mbrimmer@msn.com
Others CAPA, IPC-A-610, Process Validation, FMEA, DFM, SPC and DoE

Innovative, highly experienced leader with expertise in quality assurance, continuous improvement and operational efficiency. Recognized as go to subject matter expert in quality management systems (QMS). Leads from the front and through example. Global experience and perspective. Builds cross functional teams that collaborate to improve quality systems by simplifying requirements and revamping procedures. Specialized knowledge of ISO standards and FDA Quality System Requirements (QSR) for medical devices, aerospace and industrial manufacturing. Delivers tangible results to support business strategy. PROFESSIONAL EXPERIENCE SPACELABS HEALTHCARE INC., Snoqualmie, WA 2011-2013

Manager, Supply Chain Quality 2013 Introduced new surveillance audit approach reducing travel budget by 25% Modeled Supplier Quality Control Plans aimed at reducing supplier issues on new products Director, Global Supply Chain Quality (for OSI-Systems) 2011 2013 Established a global team of 7 Supplier Quality Engineers and 2 Regional Managers, ensuring purchased products met requirements. Implemented common practices across 5 facilities in the US, China, Indonesia and Malaysia in cooperation with 3 separate business units. A 75% reduction in product recalls associated with supplier caused defects by monitoring underperforming suppliers and implementing greater controls. Redesigned supplier corrective action request (SCAR) process, leading to an overall reduction in Defective Parts Per Million (DPPM) by 88% year over year (Y-O-Y). Revamped the Quality Management System, ensuring compliance to ISO 13485 and 21 CFR Part 820. Founded a Global Supplier Audit Program, resulting in over 70 supplier audits in the first year. Took leadership on PCBA commodities, resulting in DPPM reduction of 60% Y-O-Y. Manager, Performance Excellence 2011 2012 Led a cross-functional team of 7 Managers to monitor product performance trends and institute improvements. Utilizing Black Belt in Six Sigma, reduced 90% of solder defects on PCBAs. Provided concurrent engineering and supplier process expertise, increasing the reliability of lead wire accessory by 88%. MICHAEL P. BRIMMER CONSULTING, LLC, Seattle, WA 2010 2011

President Specialized in quality system assessments and robust solutions mitigating system deficiencies. Worked with Quality Systems Engineering (QSE) over a 4 month period, audited multiple Johnson and Johnson, Inc., to meet internal audit requisites and compliance to FDA QSR.

MICHAEL P. BRIMMER
PHYSIO-CONTROL, Redmond, WA

MBRIMMER@MSN.COM

PAGE TWO
1993 2010

Manager, Supplier Processes 2006 2010 Led compliance and efficiency of Purchasing Controls processes. Revamped purchasing control procedures in response to FDA consent decree to federal regulation 21 CFR Part 820, resulting in processes that exceeded FDA requirements. Established a supplier request for design change (RDC) process, early supplier integration (ESI) model, Design for Manufacturability (DFM) principles, Supplier P-FMEA, process validation and score carding, reducing new product time to market and exceeding requirements for compliance to FDA Quality System Requirements (QSR). Principle Supplier Quality Engineer 2003 2006 Led team in overall supplier quality, including supplier audit and corrective action. Managed supplier audit scheduling, monthly KPI and presentation for management review. Utilized Black Belt in Six Sigma establishing model for the control of underperforming suppliers, achieving DPPM targets in 3 months. Coordinated audit schedule, compiled summary results reports, actively contributing to 6, 2-man teams, completing audits of 48 suppliers in less than 6 months. Manager, Supplier Quality Engineering 1994 2003 Managed team of 6 Supplier Quality Engineers, global supply base was serving 4 active end-item production lines and two accessory lines. Re-established department to commodity based teams and streamlined SQE and incoming quality assurance systems, enabling department to gain efficiencies with declining resources. Acted as the subject matter expert for Medtronic on supplier selection, audit and management. Trained top 50 suppliers on process-failure mode effects analysis (P-FMEA) process control planning and process validation, reducing SCARs by 30%. Managed a budget over $3M, then reduced departmental costs from to $717K over 2 years. Other Member of Whos Who in America Medtronic: Star of Excellence Award 2 time winner Veteran U.S. Army

EDUCATION AND CERTIFICATIONS MBA: City University, Seattle, WA BS: Physical Metallurgy / Material Science & Engineering, Washington State University, Pullman, WA