Quality consultant for support of internal auditing for ISO 9001:2015, ISO 14001:2015, ISO 13485:2016, quality improvement projects, or quality problem solving in the Chicago area.

An internal consulting position reporting to the Corporate Quality Director, leading quality improvement projects for medical and military batteries, managing the quality and environmental system and internal audits, and planning for compliance upgrades to ISO 9001:2015, ISO 13485:2016, FDA QSR, and ISO 14001:2015.Selected accomplishments include:• Took over location internal audit program 4 months prior to scheduled ISO recertification for existing ISO standards 9001:2008, 13485:2003, 14001:2004 => identified 10 major gaps. Led cross functional team of managers across HR/Training, Supply Chain, Program Management, Engineering, SMT, Production, and the Warehouse to get corrective action in place for the audit (only 3 minor findings identified during full re-certification to all 3 standards). • Developed transition plan for organization to comply with 3 new ISO standards plus FDA QSR: mapped all 4 standards together, highlighted deltas from old requirements, identified gaps in organizations compliance (to both old and new requirements), mapped gaps to new processes required/existing processes to be updated, and identified process owners responsible for implementing improvements.• In support of location manufacturing and quality team, lead 8D analysis of reported field failure for class 3 medical device, and led implementation of successful resistance welding corrective action to eliminate potential sources of operator variation identified as root cause.• To address chronic low level issues of label defects on class 3 medical device, analyzed failure modes, and determined 15 corrective actions (some in concert with proposed customer design improvements) to continuously reduce these occurrences.

Head of Quality Department reporting to Vice President of Operations for design and devlopment of military, medical, and industrial batteries. Position included responsibility for all aspects of quality and safety, quality improvement and management of Quality and Environmental systems in Woodridge, Malaysia, and China. Selected accomplishments include:• Instituted 8D failure analysis for all Woodridge field failures and significant production yield issues. > Field failures rate reduced by a factor of 3 (Return $s reduced by a factor of 5). > Production scrap reduced by a factor of almost 2 (Production DPPM by a factor of 3).• Worked closely with Program Management VP to define New Product Introduction Gate System • Continually enhanced Quality System processes – passed full recertification to ISO 9001:2008, 14001:2004, and 13485:2003 with only 2 minor findings.• Led effort with Malaysia to enhance their quality program to excel during Bose audit and secure business to build battery for major new product at that site.

Head of Quality Department and member of Leadership Team, reporting to the President. Managed and improved product quality and Quality Systems for the Woodridge and Malaysia facilities designing and manufacturing customer lithium-ion batteries. Selected accomplishments include:• Enhanced quality system process controls: significant improvements in supplier management, change management, metrics, control on non-conforming material, incoming inspection.• Extended quality system to add required controls to comply with ISO medical quality standard (13485:2003) to support class 3 medical product.• Provided extensive quality support and data analysis to enable the successful introduction of prototype conformable wearable battery for the Army.• Received President's Award for contributions in 2010

Managed the Quality System and operational performance (quality cost, defects, timeliness) at manufacturer of specialty fiber optic cables, opto-electronic transceivers, and video transport products. Led both strategic and tactical quality control and improvement activities. Managed quality for supplier, production, and customer aspects of the business. As a member of the senior leadership team, worked closely with Engineering, Customer Service, Operations, and Sales.• Coordinated yield improvement (50%->90+%) for Harsh Environment optical connectors. Led two FMEA teams of Engineering and Manufacturing to identify risks, Critical To Quality factors, control plans, and longer term improvement projects.• Reduced cost/increased consistency by integrating quality systems/processes across several ISO 9001:2000 registered divisions. Reduced quality staff by one-third without impacting quality.• Facilitated senior leadership team in definition of strategic goals and metrics.• Led redesign of New Product Introduction Process to improve quality and reduce cycle time. • Convinced organization to acquire software (EtQ) to automate workflows, reporting, record keeping. Led design and implementation. Eng. change request time: months -> weeks.• Defined Outsourcing Quality Management strategy to qualify suppliers and products. • Led RoHS and other environmental compliance efforts: directed data collection, designed data structures, drove improvements needed to achieve compliance across organization.

Pre-eminent R&D organization in the U.S. at this time, developing Switching System software and hardware that powered the AT&T long distance network and other local networks. Manager of Quality, System Test, Reliability, Performance, and Integration teams working on ultra-reliable processors and operating systems. Selected accomplishments include:• Held a leadership role in 2 projects that were winners of Bell Lab's President's Award. • Led Quality and Customer Satisfaction effort as part of the Toll and 5ESS Switch Projects ($2B and $5B revenue, respectively) delivering complex HW/SW products (millions of lines of real-time code) with 99.9999% reliability.• Led management of quality system that achieved this reliability - strategic goal setting; metrics; auditing; process definition, assessment and improvement; ISO/TL9000 registration, recognition.• Facilitated Executive Software Leadership Council for Switching Division President ($5B division). • As Corporate Dean for SEI Software CMM training, developed course for Lucent, also a member of Switching Division Malcolm Baldrige team.

Engineer on Switching System projects in designer, architecture, integration, and system test roles. Selected accomplishments include:• Test: Designed and executed integration/system test for initial deployment of ultra-reliable processor and highly reliable UNIX operating system (ancestor of today’s LINUX). Specialized in initialization and fault recovery (3B20D). • Integration: Lead engineer for hardware/software integration team integrating first release of major new digital local switch (5ESS). • Designer: Developed switching system software features and debugged field problems (Operator System).