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senior quality engineer resume example with 20+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Career Overview

Productive and dependable professional with diverse experience in regulated manufacturing fields including Food, Medical Devices and Biotechnology. A customer focused multi-tasker is seeking a position commensurate with my qualifications in a progressive company. Seasoned with over 25 years of increasing responsibility, my industry positions include: Chemistry Manufacturing, USDA Meat Cutting QA/QC & Sanitation, Food Warehousing & Distribution, Device Manufacturing, HACCP, Food Safety Instruction, Product Development and Process Validation.


accept challenges and produce immediate results. Possesses a unique skill set of technical know-how, business leadership, creative, analytical and critical thinking.

Qualifications
  • 25 years in Manufacturing
  • Removed FDA Warning Letter
  • Restored ISO certification
  • Validated Manufacturing Processes
  • FDA QSRCertified
  • Quality Audits Certified
  • Formulations Chemistry
  • Packaging, Labeling inspection
  • Established Equipment Cal & PM Program
  • Worked in Microbiology
  • Researcher in Genetic Engineering Lab
  • BA Biochemistry minor Cell Biology
  • HACCP Food Safety Certified
Technical Skills
•Chemistry Formulations
HACCP / Food Code
Compliance USDA/FDA
QA/RA Engineering
Vendor Audits & Inspection
ISO 9001, ISO 13485
Accomplishments
  • Executive Highlights As a senior QA team member brought Mercury Medical out of FDA 483, helped to re-establish Quality Control and ISO certification, co-designed and validated product and manufacturing processes, worked with International Marketing to re-establish compliance to US Customs, CE Mark, revised Supplier Selection and performed supplier Audits, Authored and resolved Internal Audit Observations through CAPA implementation, revisions to Quality SOP's, Manufacturing Documents, Equipment Calibration, Forms and Work Instructions.
  • Effected worker training and policy implementation under my supervision, US Foodservice (12 billion in annual sales) was awarded American Sanitation Institute's highest grade for food safety compliance as compared to other US Foodservice divisions, weighing heavily in gaining a multi-million dollar, 7-year Western Pacific Military Provisions sole supplier contract.
  • Executive Highlights Continued While Product Development Scientist, I facilitated team activities using brainstorming, logic and reasoning to identify complex manufacturing problems in producing pregnancy test kits, revised QC materials inspection methods based on Scientific Method and Statistical Analysis allowing production to proceed, saving six-million in materials costs and justifying a company-wide bonus.
  • My instructional programs were promoted by the California Restaurant Association, and produced a 98% success rate in certifying foodservice managers taking the California State exam.
  • Authored two divisions' QA manual, and established the USDA required Hazard Analysis and Critical Control Points (HACCP) program before the 1998 deadline, under budget, for the purpose of identifying, abating, or reducing to safe levels biological, chemical or physical hazards that affect either food safety or the health of the workers or customers.
  • Facilitated the Quality activities of meat packing, warehousing, and distribution departments within established Federal and State guidelines and represented management's position to government regulators, inside and outside customers, during audits, investigations, or resolution of program violations.
  • Performed laboratory experiments, Scaled-up R&D working model into full-scale production.
  • Kits were re-engineered from costly refrigerated storage into a cost-effective shelf-stable format including Europe's top-selling Lyme disease test.
Work Experience
Senior Quality Engineer, 03/2005 - Current
Johnson & Johnson Missouri, MO,
  • Formulation Chemist for Capnography devices, Senior Quality Engineer responsible for ...implementing internal company policies and procedures independently or as directed by the VP of Quality and Engineering including; compliance to applicable FDA Quality System Regulations, ISO 13485, Florida State and Pinellas County ordinances, UL, OSHA, EPA, and ASTM during production operations.
  • Instructs Departmental Managers and Supervisors with regards to daily Quality/Regulatory issues.
  • MDR Investigation, writing and FDA communication.
  • Effects/ directs co-workers in Document Control Records and Procedures, resolution and investigation of CAPA's, Customer Complaints non-conformances and trends data in concise and useable formats.
  • Lead Chemist in Manufacturing Capnography Device Components.
  • Directs/assists in Inspection of raw materials, final inspections, and all aspects of daily Manufacturing and Engineering processes from a compliance perspective.
  • Effects recall activities for either manufactured or distributed product.
  • Submits Medical Device and Baseline Reports to FDA.
  • Performs Suppli.er Audits, Qualification
Serve Safe Instructor - California Restaurant Association, 11/2001 - 07/2004
City, STATE,
  • Provided National Food Code Compliance certification training/seminars at US Foodservice under sponsorship from the National Restaurant Association as required by California Food Code Statute.
HACCP Coordinator / Microbiologist/QC Inspector, 02/1998 - 11/2001
NA , STATE,
  • Managed HACCP Program (food safety compliance) in Meat Packing, Warehouses, and Transportation, developed quality standards and trained workers. Microbiology, Compliance
Product Development and Transfer Scientist, 07/1992 - 07/1995
U S Foodservice - Joseph Webb Operations, Vista City, STATE,
  • Scientist Level 1- New Product Development of Medical Devices, Chemistry Manufacturing, Process Improvement.
Supervisor Quality Control & Product Development, 09/1989 - 07/1992
Pacific Biotech Inc City, STATE,
  • Scale up R&D into full production of Medical Diagnostic Devices for the Clinical Lab.
Technician Level 2 / Special Projects MBI, 02/1986 - 09/1989
General Biometrics Inc City, STATE,
  • Technician Level 2 - Medical Devices and Pharmaceutical Manufacturing in Immunodiagnostics partnered with Medical Biology Institute.
Education and Training
BA: Biochemistry, Expected in
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University of Arizona - ,
GPA:
Status -
BA: Biochemistry / minor Cell & Molecular Biology, Expected in
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University of Arizona - Tucson,
GPA:
Status -
Certificates / License AAMI Quality System Regulation Compliance Certificate, ASQ Supplier Auditing, ASQ Supplier Selection, Bloodborne Pathogen, IETP Small Business Management Southwest College, Florida Teaching Certificate, National Restaurant ServeSafe® Train the Trainer, Sanitation and HACCP - Food Safe Labs Inc., Hazard Analysis & CCP's for Meat, Poultry & Seafood - USDA / FDA, Microcomputer Training - Executrain , ISO 9000, GMP, GLP - Cal State Fullerton, SCUBA Diver Certification -PADI, Florida Class E Driver's License: , Expected in
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GPA:
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IETP: Small Business Management, Expected in
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Southwest College - Chula Vista, CA
GPA:
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IETP: Small Business Management, Expected in
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Southwest College - Chula Vista, CA
GPA:
Status -
BA: Biochemistry, Expected in
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University of Arizona - ,
GPA:
Status -
BA: Biochemistry / minor Ecology & Evolutionary Biol, Expected in
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University of Arizona - Tucson,
GPA:
Status -
Certificates / License AAMI Quality System Regulation Compliance Certificate, ASQ Supplier Auditing, ASQ Supplier Selection, Bloodborne Pathogen, IETP Small Business Management Southwest College, Florida Teaching Certificate, National Restaurant ServeSafe® Train the Trainer, Sanitation and HACCP - Food Safe Labs Inc., Hazard Analysis & CCP's for Meat, Poultry & Seafood - USDA / FDA, Microcomputer Training - Executrain , ISO 9000, GMP, GLP -Cal State Fullerton, SCUBA Diver Certification -PADI, Florida Class E Driver's License: , Expected in
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- ,
GPA:
Status -
Additional Information
  • Activities / Interests: Add interest in gourmet cooking, previous experience in foodservice - Saga / black angus, etc. Wine Making - from Home Grown Tropical Fruits Garden Club iIle de trésor club de Petanque) Traveled Extensively through Europe Conversational French Biochemistry Chemistry Manufacturing HACCP Coordinator / Microbiology US Foodservice Vista, California California Restaurant Association Food Safety Instructor in ServSafe Quality Control / Quality Assurance http://resume.livecareer.com//builder/load.aspx#docID=28625034 go to this site. livecareer.com http://jobsearch.about.com/od/jobsearchglossary/g/linkedin.htm account id 49707942

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Resume Overview

School Attended

  • University of Arizona
  • University of Arizona
  • Southwest College
  • Southwest College
  • University of Arizona
  • University of Arizona

Job Titles Held:

  • Senior Quality Engineer
  • Serve Safe Instructor - California Restaurant Association
  • HACCP Coordinator / Microbiologist/QC Inspector
  • Product Development and Transfer Scientist
  • Supervisor Quality Control & Product Development
  • Technician Level 2 / Special Projects MBI

Degrees

  • BA
  • BA
  • Certificates / License AAMI Quality System Regulation Compliance Certificate, ASQ Supplier Auditing, ASQ Supplier Selection, Bloodborne Pathogen, IETP Small Business Management Southwest College, Florida Teaching Certificate, National Restaurant ServeSafe® Train the Trainer, Sanitation and HACCP - Food Safe Labs Inc., Hazard Analysis & CCP's for Meat, Poultry & Seafood - USDA / FDA, Microcomputer Training - Executrain , ISO 9000, GMP, GLP - Cal State Fullerton, SCUBA Diver Certification -PADI, Florida Class E Driver's License
  • IETP
  • IETP
  • BA
  • BA
  • Certificates / License AAMI Quality System Regulation Compliance Certificate, ASQ Supplier Auditing, ASQ Supplier Selection, Bloodborne Pathogen, IETP Small Business Management Southwest College, Florida Teaching Certificate, National Restaurant ServeSafe® Train the Trainer, Sanitation and HACCP - Food Safe Labs Inc., Hazard Analysis & CCP's for Meat, Poultry & Seafood - USDA / FDA, Microcomputer Training - Executrain , ISO 9000, GMP, GLP -Cal State Fullerton, SCUBA Diver Certification -PADI, Florida Class E Driver's License

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