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33 Parremo
Mission Viejo, CA 92692
(805) 907-6905
A Quality Engineering position utilizing experience gained in quality control, q
uality assurance, and dimensional engineering.
Bachelor of Science in Chemical Engineering, Michigan State University
ASQ Certified Quality Engineer (CQE), December 2008
Six Sigma Black Belt, May 2009
Industry: Medical Device
Business: Manufacture of capital equipment that sterilizes surgical instruments
Quality Engineer II, 6 Month Contract Assignment, 2/10 - present
* Participate in the MRB process which includes reviewing Nonconforming Material
Reports (NCR) and dispositioning the nonconforming material.
* Review supplier corrective actions for effectiveness and track to closure.
* Review and approve Change Orders to revise existing procedures and drawings an
d to implement new procedure and drawings.
* Create Inspection Plans for Receiving Inspection Inspectors to use to inspect
incoming parts from suppliers.
* Audit suppliers for conformance to ISO 9001 and track supplier's corrective a
ctions to audit findings to closure.
* Provide support to R and D for new product launches which includes reviewing
First Article Inspection Reports and working with R and D Engineers to resolve d
rawing issues.
EXTRUMED, Placentia, CA
Industry: Medical Device
Business: Supplier of custom precision thermoplastic extruded tubes to medical
device companies whose applications include class I, II, and III medical devices
in the areas of Vascular Intervention, including coronary, peripheral and neur
ovascular, Cardiac Rhythm Management (pacemakers), Neurostimulation, Endosurgery
and Vascular Access (catheters).
Quality Engineer, 3 Month Contract Assignment, 5/09 - 8/09
* Provided validation support for equipment, systems and processes (IQ, OQ, PQ,
PVP and PVR) with protocols and reports.
* CAPA Coordinator for Corrective Action Reports (CAR's), Nonconformance Reports
, (NCR's) and Preventive Action Reports (PAR's).
* Developed a new CAPA system to improve the effectiveness and efficiency of fo
rmer CAPA System.
* Revised and implemented new ISO 13485 procedures for protocols, validations, a
nd the CAPA process.
* Reviewed Master Record Specifications (MRS) for accuracy.
* Developed PFMEA and control plans.
Quality Engineer, 2006-2008
* Facilitated the corrective action process and developed action plans to close
corrective actions for customer returns.
* Participated in TS 16949 (ISO 9001 plus automotive specific requirements) audi
ts and certification process.
* Performed daily line audits to ensure that production personnel were following
procedures and meeting requirements.
* Reviewed SPC data and charts to determine if the frequency and quantity of SPC
checks were adequate and to determine if the processes were in control.
* Facilitated the scrap reduction process via review of scrap data and the creat
ion of action plans to close out open scrap issues.
* Supervised Technicians and Quality Inspectors to ensure that all quality
requirements/specifications for prototype parts were met before shipment to the
* Worked with Program Managers, Manufacturing Engineers, Line Leads, Production
Personnel, Technicians, and Quality Inspectors to ensure that all PPAP requireme
nts were met in order to gain full approval from the customer.
KAVLICO, Moorpark, CA
Quality Engineer, 2004-2006
* Facilitated the corrective action process and developed action plans to close
corrective actions for customer returns and continuous conformance test failures
* Participated in the Material Review Board process to disposition nonconforming
* Used SPC to monitor and react to out of control process conditions.
* Performed MSA studies to qualify measurement systems.
* Updated control plans and startup checklists for corrective actions
and continuous improvement.
* Performed capability studies for new part launches and software validation.
* Supervised Quality Technicians to ensure production quality requirements were
* Lead Production Line Teams to resolve immediate quality concerns and to addres
s daily quality metrics.
* Participated in TS 16949 (ISO 9001 plus automotive specific requirements)
audits and certification process.
DELPHI (MSX International), Troy, MI
Supplier Quality Engineer, 2003-2004
* Supported the Columbus, OH plant to help resolve quality issues and assist in
the PPAP submission process to the plant for 250 suppliers.
* Participated in product developments teams to resolve supplier quality issues
and coordinate the PPAP submission process to customers for engineering changes
and launching new parts.
* Reviewed and evaluated supplier change requests for potential product
and process changes.
* Reviewed and evaluated suppliers' root cause analysis to 8d's or problem cases
* Facilitated the Quality Focus Supplier (QFS) process with suppliers which incl
udes quality metric progress reporting and corrective actions for reduction in P
PM, problem case, and First Time Quality data and to improve on time delivery.
* Visited suppliers to review recent problem cases for root cause/corrective act
ion effectiveness and audit Process Flow Diagrams, Control Plans, and PFMEA's fo
r updates.
* Developed corrective action plans jointly with suppliers to address open issue
s at the close of supplier visits.
Quality Engineer, 2001-2003
* Promoted problem resolution through 8D review and effective countermeasure imp
* Assured appropriate revisions for PFMEA's and control plans for process improv
* Developed concrete action plans jointly with suppliers for improvements using
* Conducted process reviews and reviewed mass production readiness for product l
aunches at supplier facilities.
* Tracked and reviewed supplier PPAP status for conformance to engineering speci
fications and requirements.
* Developed critical and significant characteristics from assembly drawings and
similar part quality history to be used in control plans.
* Microsoft Office
* Computer Aided Design (experience with Catia, CM4D, Solutions, CMDANA)
* Biomedical Auditing
* Geometric Dimensioning and Tolerancing (GD and T)
* Statistical Process Control (SPC)
* 8d Problem Solving
* Advanced Production Quality Planning (APQP)
* First Time Quality (FTQ)
* Lean Manufacturing