Quality Engineer Continuous Improvement
Resume:
Annette M. Valdez
Scottsdale AZ
**********@*****.***
QUALIFICATION
Over 25 + years successful Quality programs involving multi-state facilities.
QS/TS16949 Lead Auditing
QS/ISO 9001-2008 Lead Auditing
AS-9100 rev b. Lead Auditing
ISO 14001 Environment Lead Auditing
ISO 13485 - 2003 Lead Auditor
Completed ASQ Certified Quality Manager (CQM)
Completed ASQ Certified Quality Auditor (CQA)
Global 8D Process Trained and Trainer Program Ford Facilities.
FAI, PPAP, DFMEA, PFMEA and Change over Reduction...
FDA GMP Médical Devise 21 CFR 820 Certification
FDA GMP Pharmaceutical 21 CFR 210 - 211 Certification
FDA HACCP Training
FDA GLP 21 CFR 58 Certification
510K and 483 experience
Supplier Development Programs/Launch for new product and APQP programs
Set-up Registration for Company’s ISO 14001, TS 16949, ISO 9001-2008 and QS-9000
Audit Paint, Manufacturing, Stamping, Assembly, Machining, Electronic Components Etc. Multiple Facilities
SAP/ERP Training
Greenbelt and Black belt Projects Completed.
Experience in Medical, Aerospace, Environmental, Turbo and Gas and Automotive
Training Coordinator for 14001-EMS Program and ISO 9001-2000 Programs
Associate in Dental Technician and Business.
Over 25 + years in Supplier Quality Engineer Auditing experience.
PROFESSIONAL EXPERIENCE
INVACARE Elyria Ohio
Supplier Quality Engineer 8/17 – 4/18
New Product Launch, PFMEA, PPAP, Training and External Auditing Set-up SQD Program. Quality Management System knowledge, inspection planning, functional test application strategy, and overall process control from a risk mitigation approach. Leadership in training and mentoring the ability to interpret Engineering prints, specifications and Geometrical Dimensioning and Tolerance.
Philips Richfield Ohio
Supplier Quality Engineer 3/15 - 3/17
New Product Launch, PFMEA, PPAP, Training and External Auditing Set-up SQD Program. Quality Management System knowledge, inspection planning, functional test application strategy, and overall process control from a risk mitigation approach. Leadership in training and mentoring the ability to interpret Engineering prints, specifications and Geometrical Dimensioning and Tolerance.
AMI Akron, Ohio
Supplier Quality Engineer 07/13 – 11/14
New Product Launch, PFMEA, PPAP, Training and Auditing Kaizen for new product lines. Worked at three facility setting up New Quality Programs and inspection programs.
Philips Healthcare, Cleveland, Ohio
Supplier Quality Engineerr 01/10 - 01/13 2/17 6/17
Supplier Audits, First Article Inspections with supplier base, Continuous Improvement Development,
Work supplier quality with Philips Engineers. Completed 22 Supplier Audits last year and 510K
Projects.
Goodrich Landing Gear, Cleveland, Ohio
Supplier Quality Engineer 02/09 – 07/09
First Article Inspections with supplier base. Continuous Improvement Development with supplier base. Work supplier quality issues with Goodrich Engineers. Supplier auditing. Completed 15 supplier audits and set-up supplier scorecards.
A. Schulmann/Inzision, Sharon Center, Ohio
Continuous Improvement Coordinator 01/08 – 12/08
Implemented ISO 9001-2000 program, successful internal audits, customer audits and registrar
audits. Developed and implemented supplier and customer qualifications procedures which
includes monthly evaluations and corrective actions. Set-up and implemented Inspection on Manufacture floor, Suppliers and Customer base.
Swagelok Company, Solon, Ohio
Supplier Development Engineer 10/06 – 12/07
Successful internal audits, desk audits. Developed and implemented inventory, product identification,
and procedures with supplier base. Internal auditing in the ISO 14001 EMS program. Completed 17
Supplier Audits and completed a fastener programm.
Rolls-Royce, Mt. Vernon, Ohio
Supplier Development Leader and Supplier Quality Engineer 2/04 – 10/06
Implemented ISO 9001-2000 procedures, successful internal audits, supplier audits and registrar
audits. Developed and implemented supplier and customer qualifications procedures which
includes monthly evaluations and corrective actions. Set-up and implemented Inspection with third
party inspection worked with supplier inspection programs. AS-9001 procedure set-up team along
with SAP training, and set-up Supplier scorecard process.
GM, Lansing, Michigan
Quality Manager and Supplier Quality Engineer / Contracted SSR Program 4/03 – 1/04
First Article Inspections with supplier base. Continuous Improvement Development with supplier
base. Work supplier quality issues with GM Engineers. 27 Supplier audits. Set-up inspection and
rework stations with supplier and customer base and APQP and PPAP.
Eaton Aeroquip, Jackson, Michigan
14001 EMS Coordinator, Lead Auditor, Trainer, Quality Engineer, Supplier Liaison 9/00 – 3/03
Implemented ISO 14001 program, successful internal audits, customer audits and registrar
audits. Developed and implemented supplier and customer qualifications procedures which
includes monthly evaluations and corrective actions. Set-up and implemented Inspection on
Manufacture floor.
Multi Facility Experience in automotive, aerospace, medical oil & gas and variety of tier 1 facility supplier audits
Contract positions working supplier development,
Long an Short Term Position working FDA an new product design and QMS auditing
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