Engineer Quality
Resume:
SHIRLEY J. CARAWAY-BROWN
Champlin, Minnesota 55316
E-mail: ********@*********.***
SENIOR QUALITY ENGINEER
QUALIFICATION PROFILE:
Broad experience in all aspects of quality engineering in the automotive, military, and medical-device
industries.
Key areas of expertise includes:
• Quality Standards compliance for EN ISO 9001:2000, AS9100, Capability Maturity Model
Integration, (levels 4&5) (CMMI), ISO 13485:2003, current Good Manufacturing Practices
(cGMP’s), FDA QSR 21 CFR 820, Medical Device Directive (MDD), CE Marking, EN ISO
14971, & EN 60601-1-1
Advanced Quality Planning
•
Lead Auditor compliance to EN ISO 9001:2000, AS9100 B, CMMI and ISO 13485:2003
•
standards
Managed internal and external customer relations impacting Quality
•
Led the implementation and identification of assuring effective problem solving
•
methodologies including corrective action, preventive action (CAPA), 8-discipline, root
cause problem solving tool (8D), and statistical process control (SPC) systems designed
to meet or exceed internal and external quality issues
Provided focused quality engineering support within new product development,
•
operational
and system / service support.
Identified and implemented effective process control systems to support the development,
•
qualification, and ongoing manufacturing of products to meet or exceed internal and external
requirements.
MAJOR RESPONSIBILITIES & ACCOMPLISHMENTS:
QUALITY ENGINEER
• Managed quality teams who inspected incoming product, in-process inspection, and final
inspection to assure product conformation to quality test parameters.
• Developed quality plans to provide guidelines for inspection and testing to meet customer quality
standards
Proactively investigated, identified, and implemented best-in-class quality engineering
•
practices (i.e. CAPA, 8D, and SPC) designed to meet or exceed internal and external
quality issues
Developed, established, and maintained quality engineering methodologies, systems and practices
•
that met company, customer, and quality / regulatory requirements based on industry standards
Reviewed certification of compliance or test reports to determine verification and validation
•
Oversaw design history file reviews and updated the necessary risk assessment and Design FMEA
•
documentation on existing market released devices. Confirmed and documented traceability
between objective evidence documentation and MDD Conformity requirements.
Generated and updated Declaration of Conformities (DoCs), Standard Gap Analyses, Essential
•
Requirements Matrixes to conform to MDD requirements
Confirmed and documented traceability between objective evidence documentation to
•
(BS EN 60601-1-1 & EN 14971) standard requirements along with all relevant standards.
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Shirley J. Caraway-Brown
MAJOR RESPONSIBILITIES & ACCOMPLISHMENTS (continued):
LEAD AUDITOR
• Achieved division-wide external audit compliance score of 97.5% for three consecutive years.
• Subject-matter-expert for internal audit and corporate teams
• Managed division audit training, responsible for training internal and program auditors,
scheduling audits, conducting audits, writing audit reports and issuing corrective and preventive
action reports.
• Managed, planned, designed and conducted corporate, product, process and system audits from
concept to closure.
• Conducted new-hire training in quality procedures, techniques and concepts in accordance with
EN ISO 9001, AS9100B, CMMI (level 4 & 5), FDA, 21 CFR 820, and ISO13485 standards and
assisted quality teams with the ongoing continuous improvement efforts.
• Implemented and maintained product quality documents (i.e. inspection procedures, statistical
techniques), established practical and economic quality plans for measurement and control of
materials, processes, and products with an emphasis on prevention.
• Prepared and presented reports to senior management
CAREER HISTORY (Contract / Direct):
Reliability Engineer (Post Production) Senior Quality Assurance Engineer
Medtronic Incorporated (2009 – 2010) Acist, Medical Systems Incorporated,
CRDM, Mounds View Minnesota (contract) A Bracco Company (2002-1998)
Eden Prairie, Minnesota (direct hire)
Lead Auditor/Quality Engineer
Senior Quality Engineering Scientist
Lockheed Martin Corporation (2008 – 2004)
United Defense LP (1998 - 1996)
Tactical Systems, Eagan, Minnesota (direct hire)
Fridley, Minnesota (direct hire)
Product Assurance Engineer Quality Engineer
Medtronic Incorporated (2004-2003) Final Inspection / In-Process Supervisor
Cardiac Rhythm Management Division Microtron Incorporated (1995-1990)
Spring Lake Park, Minnesota (contract) Minneapolis, Minnesota (direct hire)
EDUCATION:
MASTERS OF MANUFACTURING SYSTEMS ENGINEERING (Candidate)
St. Thomas University, St. Paul, Minnesota
BACHELOR OF SCIENCE - MECHANICAL ENGINEERING
Prairie View Agriculture and Mechanical University, Prairie View, Texas
PROFESSIONAL AFFILIATIONS AND CERTIFICATIONS:
• American Society of Quality
• Regulatory Affairs Certification (North Hennepin Community College)
• Auditor / Lead Auditor of Quality Systems ISO9001:2000, ISO13485, AS9100B certificate
• Mini-Medical Program Management Certification (St. Thomas University)
• Certified Supervisor (Employees Association, Minneapolis, MN)
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