Quality Assurance Project Management
Resume:
Lisa M. Carter
Painesville, OH 44077
adztvv@r.postjobfree.com
Lisa Carter
Objective
A proactive and result oriented professional with over 20 years of experience in Quality Management System deployment & Continuous Improvement. Implement the latest quality processes and bring direct and measurable profit improvement to a professional manufacturing organization through my years of experience in the field of quality management with demonstrated ability to deliver mission-critical results.
Professional Experience
03/2022 - Present Avery Dennison – Performance Tapes North America & Medical Painesville & Mentor, OH
Regional Quality Assurance Manager
Established quality team priorities related to process evaluations. The focus was on the integration of departments such as client implementation, account management, education, training, and project management.
CAPA, customer complaints & risk management utilizing the DAMIC principles.
ISO 13485 and FDA 21 CFR Part 820 Compliance and Certification
ISO 9001:2016 Compliance and Certification – local and remote facilities
Developed and implemented Regional Strategic Quality Plan for 2023 - 2024.
Utilized lean / six sigma tools for the organization to help realized improvements and increase efficiencies on the coating and finishing lines.
Demonstrated effective leadership skills.
Improved TAT for customer complaint for closure from 63-day average down to 27.3 day average within 1 year.
Developed and Implemented quality inspection testing on New Product Developments.
Understand customer needs and industry trends to improve customer quality.
Develop and implement customer Quality Team Improvement Plans and standardized work.
Facilitated Several Meetings: APQP, FMEA, DFMEA, PFMEA, PPAP, CAPA, MRB Review and Supplier SCAR Review
01/2017- 03/2022 Norman Noble Inc. Highland Heights, OH
Manager, Quality Control
Prepared Level 3 daily reporting for DMS Meetings
Assists in the establishment of priorities related to process evaluations. The focus was on the integration of departments such as client implementation, account management, education, and project management.
CAPA, customer complaints & risk management utilizing the DAMIC principles
ISO 13485 and FDA 21 CFR Part 820 Compliance and Certification
ISO Certified Lead Auditor, ASQ Certified
APQP, FMEA, DFMEA, PFMEA, PPAP
Implemented and introduced CT Scanner Inspection using GeoMagic software
Developed and implemented inspection plans using the following Equipment:
Zeiss CMM, Calypso software
OGP Smart Scopes, MeasureMind Software and Zone 3
Starrett Vertical and Horizontal Digital Comparators
Fine Scan
Micro Vu system (manual and automated)
Introduced lean / six sigma to the organization and realized improvements in the efficiencies
Demonstrated effective leadership skills and improved MFA score from 3.2 to a 5.9 overall.
Increased Inspection through put by 63% by developing new inspection methods and inspection fixturing.
Improved first piece inspection TAT from 1.3 hours to complete to .25 hours.
Understand customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment.
Develop and implement customer Quality Improvement Plans
03/2014- 11/2016 UTC Aerospace Systems Uniontown, OH
Manager, Process Improvement and Quality Assurance
Prepared SIS Level 1 & 2 monthly reporting for PDPR, CAB and SRR (CoPQ and DQ Metrics reports and presentations)
Developed Production & Process Control Audits
Successful experience managing external surveillance activities involving global regulatory agencies (ISO, AS9100, NADCAP)
Demonstrated effective leadership skills and improved MFA score from 3.5 to a 5.8 overall within 1 year.
Understand customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment.
Implementation of PFMEA and UPPAP programs
Develop and implement customer Quality Improvement Plans
POC for major customers such as Airbus, Boeing, Rolls Royce, Gulfstream, Bombardier and Embraer.
2012- 2014 Gurley Precision Instruments, Inc. Troy, NY
Vice President - Quality
Implementation of AS9100 Compliance and Certification
ISO 9001:2008 and AS9100 Certified Lead Auditor
Design controls, design verification & validation activities
Production & process controls
CAPA, complaints & risk management
Successful experience managing external surveillance activities involving global regulatory agencies
(ISO, AS9100, NADCAP, etc.)
Demonstrated effective interpersonal & networking skills.
Development of FMEA, DFMEA, PFMEA and PPAP programs.
Developed and implemented ITAR/EAR Program
ITAR/EAR Company Empowered Official
Nonconforming Material Coordinator
Identification and Traceability Programs
Corrective and Preventative Action solving with implementation of Customer Fast Response program.
2010- 2012 Camoplast Solideal Plattsburg, NY
Quality Manager
2006- 2010 DexM Corporation Waukesha, WI
Operations Manager & Quality Manager - Manufacturing and Distribution Center
2002-2005 Ingersoll-Rand Winch & High Capacity Hoist Seattle, WA
Quality Assurance Consultant
2000-2002 Atchison Steel Casting St Josephs, MO
Quality Assurance Supervisor
Education
2010-2012 University of Phoenix Phoenix, AZ
MBA Program Business Management GPA 3.45
1991-1995 West Virginia University Institute of Tech. Montgomery, WV
BS Industrial Engineering
AS Drafting and Design
Skills
Strategic Quality Planning and Alignment, Lean / Six Sigma Facilitation And Training, Accreditation & Regulatory Compliance, Supplier Quality Mgmt, Measurement Systems Analysis, Independent Verification And Validation, Profit Improvement; Cost Reductions, Productivity; Efficiency Optimization, Voice Of The Customer; Business, Cost Of Poor Quality, Budget Management, Project Management, Learning Development, Business Analytics
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