Lea C. Email & Phone Number

Algonquin, Il, Us

Charlotte, North Carolina, Us

- Spearheaded over 20 8Ds and root causes analyses for internal and external nonconformances- Employed immediate containment actions within first week of each nonconformance reported; successfully driving corrective and preventative actions- Steered cross functional meetings with global teams in Korea, China, UK, India, and USA- Powered over 18 internal audits for ISO 9001 and ISO/IEC 80079-34 to completion- Implemented over 15 continuous improvement projects to support the business and manufacturing facility including improved inspection plans, manufacturing control, and change process optimization- Collaborated with 12 different regulatory agencies on QMS and Product Audits to comply with Product Certifications for IECEx/ATEX, Performance, Electrical Safety, SIL, and Marine application, and facility certification to ISO 9001- Led development and implementation of new Variance Notice process for Product and Process Deviations involving 5 different functional groups - Developed and trained an Internal Audit team of 6 internal auditors from different functional groups including Production, Design Validation, Quality, and Regulatory Engineering- Conducted at least 10 major trainings for facility personnel including material on ATEX/IECEx, Good Documentation Practices, Quality Management Systems, Internal and External Audits, Change Management, Competency Requirements, and Product and Process Deviations- Collaborated on more than 10 Quality Alerts for Customer Complaints - Assumed responsibilities as Subject Matter Expert for Engineering Change Management and Variance Notice processes using Siemens Teamcenter

Irving, Texas, Us

- Orchestrated internal QMS audits and external API audits consecutive years in a row for two locations- Advanced Product Development and AIAG PPAP activities for over 20 different part numbers and 3 NPI Projects- Deciphered MSA, Gage R&R, PFMEA, and CpK data that strengthened product and supplier quality - Campaigned over 50 RCCA meetings through Six Sigma DMAIC process driving data for Lean Manufacturing practices that addressed over 90% of quality issues- Decreased manufacturing set up scrap by 25% by spearheading a Six Sigma project focused on 15 machine types - Delivered 100% of quality engineering changes from over 150 ECN and 500 CI activities - Implemented 50% of Suppler Quality Excellence Program strengthening process for Supplier Readiness, PPAPs, and SCARs - Founded and empowered BIQ Quality Engagement Committee to drive a Quality focused Culture and Continuous Improvement- Designed Power BI dashboards creating a 100% increase in communication of Internal Mfg. and Supplier defects- Investigated on average 10-15 NCRs per week and conducted defect trend analysis through SPCs via Minitab to drive 40 % of CAPA decisions

Irving, Texas, Us

- Directed, trained, and arranged priorities of 30 inspectors for 100% of inspection activities- Devised quality control activities for 5 different manufacturing groups and over 150 part numbers- Advised quality team through new practices, certifications, and team and individual development- Achieved maximum usage of quality resources for Receiving, First Article, In-process & Pre-delivery inspections, NDT Inspection (Hardness and MPI), and Hydrostatic testing - Enforced team downsizing based on business requirements while maintaining quality team effectiveness- Pioneered Employee Voluntary Gauge Purchase Program driving 25% improvement in gauge availability- Collaborated with production leads and operators for interpretation of inspection methods - Spearheaded RIW workshop for manufacturing groups experiencing high defect rates accounting for 50% of product defects

Wheeling, Il, Us

- Restructured Quality Management System and Standard Operating Procedures to comply with OECD and EPA Good Laboratory Practices - Steered ISO 17025 internal and external audits with execution of Root Cause Analysis and Corrective Actions- Coached and developed an Assistant Quality Manager who took over 25% of Quality management activities- Piloted Hazard Communication and laboratory safety training leading to 100% elimination of safety incidences - Delivered over 30 projects per year for equipment validations and employee proficiency testing accounting for 100% of laboratory QMS validation and proficiency requirements - Performed regulatory support for 20 EPA & OECD GLP projects that accounted for 60% of revenue in 2018- Supervised Quality Assurance Unit of 3 employees for 100% of EPA & OECD GLP projects- Diagnosed laboratory proficiency for over 100 standardized test methods including ISO, JIS, ASTM, OECD, MIL-STD, AOAC, AATCC, and EPA methods

Wheeling, Il, Us

- Maximized biological and environmental testing services by offering testing for EPA and REACH registration- Orchestrated 5 Industry Tradeshows increasing new customers gained by over 25% per year- Hired 3 commercial employees and 7 microbiologists increasing laboratory personnel size by 70%- Acquired new business and 50% increase in volume of projects requiring additional team members - Facilitated 60 projects or more each month accounting for 100% of business - Reconciled account delinquencies and customer complaints reducing past due balances by 85%- Optimized customer satisfaction by completing at least 25 customer calls per week to existing customers- Headed quality and risk management processes to ensure that project work remains on track, and delivers according to project scope, schedule, and budget

Bachelor Of Science (B.S.), Environmental Science

Associate Of Science (A.S.), Environmental Science