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Quality System Auditor Resume Example

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Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Summary
Extensive Audit and Quality Engineer experience for Medical Device and Biotech companies
Highlights
Word, Excel, Outlook, PowerPoint, Oracle ERP system, MiniTab, Agile and Documentum
Education
University of California Davis, CA Expected in Bachelor of Science (BS) : - GPA :
, Expected in 2015 Certified Biomedical Auditor Refresher Course in : - GPA :
, Expected in 2012 Health Information Technology Program Management Certificate Medical Terminology and MS Office courses in : - GPA :
, Expected in ISO 9001, ISO 13485 Auditor/Lead Auditor Course Corporate Lean, Six Sigma and DMAIC Training Introduction to Electronics/Drafting and CAD courses : - GPA :
Certifications
Certified Biomedical Auditor(CBA) ISO 9001 / 13485 Lead Auditor Certified Quality Engineer (CQE) Trainer and Facilitator Vendor Qualification 21CFR 820 and ISO 13485/9001 Expertise CAPA, SCARS and Complaint Management Risk Management, Verification and Validation
Accomplishments
  • Reduced Finished Goods Defect Rate resulting in a saving of $300,000 annually Streamlined the customer complaint process and reduced average time to closure by more than 50% and reduce Foreign Matter rejections by 13% Developed partnerships, managed supplier relationship and process validations Established and Directed Internal Audit Program and verified effectiveness of CAPA Benchmarked and Standardized Risk Management and Quality System processes for multiple sites Regulatory inspections resulting in a no findings for Irvine site
Experience
Rich Products Corporation - Quality System Auditor
Ny, IL, 01/2015 - Current
  • Developed and managed the internal audit program for the Division Facilitate internal QMS Auditor training/mentoring for ISO 13485 standard Manage annual audit schedule and conduct Supplier and internal audits.   SME for international standards and regulations.
  • Execute audit, prepare audit report and coach supplier and internal auditee to ensure appropriate root cause, corrective action and confirm effectiveness. Generate and present metrics for audit program. Facilitate projects and quality initiatives, including design or recommend systems and procedures. Coached multi-disciplined audit teams and created executive reports Performed Quality Management System audits based on ISO 9001, ISO 13485 and AS9100 Provide support for FDA Inspections, Notified Body and regulatory audits.
American Axle & Manufacturing - Senior Design Quality Assurance Engineer
Saint Marys, PA, 01/2014 -
  • Quality Assurance Representative on Critical Care Ventilator Design team Provide guidance to development staff related to design control requirements and specifications Facilitated Design Reviews, DFMEA, FTA and Change Control Board with ECO Approval Implement effective Risk Management and facilitate Product Risk Analysis Provide support for FDA Inspections, Regulatory and Internal Audits CAPA Champion and Established inspection plans Revise Reliability and Software verification and validation protocols.
ABBOTT MEDICAL OPTICS - Quality Engineer (Contract position)
City, STATE, 01/2012 - 01/2013
  • Deployed risk based Complaint Management System to improve efficiency more than 20% Facilitated CAPA team to ensure effective Corrective and Preventive Action Performed Software validations and provided oversight for strategic system updates Developed Process Maps Created and Implemented procedures consistent with regulations and standards.
HONEYWELL LIFE SAFETY PRODUCTS - Quality Engineer (Contract position)
City, STATE, 01/2011 -
  • Facilitated product transfer, process redesign, PFMEA and implemented test plans Coordinated NCR and Material Review Board Issued SCAR and Managed CAPA including effectiveness checks Led Field Return investigations, SPC and Gage R&R studies Scheduled and executed Internal Audits and Supplier Audits Developed Quality metrics and trending of data Generated executive reports for audit, CAPA and field return data.
PacifiCORD - Quality Assurance Manager
City, STATE, 01/2010 -
  • Oversee all quality aspects for the collection, processing, storage, and testing of cord blood units Overall management of quality system to comply with FDA Good Tissue Practices / AABB accreditation Conducted Supplier Audits and Qualified new Lab to reduce testing costs by 17% Managed receiving inspection, Material Review Board, change orders and management reviews.
INTERFACE ASSOCIATES - Quality Engineer
City, STATE, 01/2010 -
  • Managed Customer Complaint and CAPA systems including Reporting, Investigations and Verification Coordinated Design Reviews and validated design modifications and developed process maps Managed SCARs, internal audit program and maintained applicable Quality documentation and records Trend analysis and compiled executive reports for audit, CAPA and complaint data.
DANAHER BECKMAN COULTER INC - Staff Quality System Specialist
City, STATE, 01/1992 - 01/2009
  • Established and managed the global Information Technology Quality System Standardized IT processes, Developed Gap Analysis Created Quality Manual and procedures Planned, created and executed compliance training for IT Staff related to QSR, ISO, MDD, CMDR Designed and executed internal audit program and assessed eight IT sites nationwide Facilitated management reviews including key metrics and risk analysis FMEA Senior Supplier Quality Engineer and Internal Audit Management Supplier Management for 30 strategic vendors, contract manufacturers and OEM suppliers Root Cause analysis and implemented corrective action to reduce defects / complaints saving $300K/yr Selection, Appraisal, Monitoring of critical suppliers Issued SCARS and verified effectiveness Conducted supplier audits, capability studies Cross functional complaint
Professional Affiliations
Certified Biomedical Auditor administered by American Society of Quality or ASQ ASQ Volunteer Auditor Team member Certified Quality Engineer administered by American Society of Quality or ASQ
Skills
Agile, audit report, CAD, Coach, Critical Care, documentation, Documentum, Drafting, Electronics, Engineer, ERP, functional, Health Information Technology, Information Technology, inspection, Internal Audits, Internal Audit, ISO, ISO 9001, Medical Terminology, mentoring, Excel, MS Office, Outlook, PowerPoint, Word, MiniTab, Oracle, processes, Program Management, protocols, Quality, Quality Management, Quality Assurance, receiving, Reporting, Risk Analysis, Risk Management, Six Sigma, SPC, strategic, Supplier Management, Trainer, Trend, Validation

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Resume Overview

School Attended
  • University of California
Job Titles Held:
  • Quality System Auditor
  • Senior Design Quality Assurance Engineer
  • Quality Engineer (Contract position)
  • Quality Engineer (Contract position)
  • Quality Assurance Manager
  • Quality Engineer
  • Staff Quality System Specialist
Degrees
  • Bachelor of Science (BS)
  • Certified Biomedical Auditor Refresher Course in
  • Health Information Technology Program Management Certificate Medical Terminology and MS Office courses in
  • ISO 9001, ISO 13485 Auditor/Lead Auditor Course Corporate Lean, Six Sigma and DMAIC Training Introduction to Electronics/Drafting and CAD courses

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