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Engineer Quality

Chicago, Illinois, United States
November 25, 2018

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Gerardo Arellano

*** * ******** ***, ****** IL **143




Quality assurance engineer possessing over twenty years experience in the quality field, continuous process improvements projects, thorough utilization and application of SPC, ANOVA, DOE, R&R Studies, Applied Stats. Extensive experience in ISO 9001:2015, CAPA, ISO 13485 IQ OQ PQ/ TS16949, ASME, Internal Lead Auditor, APQP, PFMEA, PPAP, EPC, WAR, etc.

Proficiency in commodities and processes such as: variety of medical components, metal stamping, laser cutting, sheet metal forming, powder coating, tube piercing, wire forming, adhesive/silicone coaters, extruders, laminating and trans laminating, plastic extrusions\injection molding including HIPS, polycarbonate, COC, PVC, Acrylic, EVA, etc. Manual and robotic mig/tig weld, machining of gray iron, cast brass, aluminum die castings, stainless steel, etc. PROFESSIONAL EXPERIENCE

ACME Alliance, Northbrook IL, June 2018 to Nov 2, 2018 Quality Assurance Engineer

● In-House QE customer representative for all quality issues.

● Responsible to review and approve PPAP submittals.

● Responsible to assist and bring closure to any new or open SCAR.

● Responsible to assist and direct continuous process improvements.

● Auditing processes for compliance to established Quality Plans.

● Assisting in procuring and needed metrology equipment to validate compliance to specs. Plitek, LLC, Des Plaines, IL - 2008 to March, 2018 Quality Assurance Engineer

● Responsible for the management of the calibration systems

● Qualify product /process requirements to ISO 13485, IQ OQ PQ Quality representative on Design & Development meetings: finalizing planning/inputs and outputs/ verifications and validations/ design transfer to manufacturing and creation of design and development master file. Review at rate process performance vs customer expectations. Participated in continuous improvement review meetings.

● Quality representative on APQP and PPAP meetings Creating Quality Plans/ MSA/ Reviewing and submitting FAIR for customer approvals. Running medical under clean room requirements.

● Extensive experience in CAPA, including Root Cause Analysis and audit for effectiveness

● Internal lead auditor to ISO 13485/ ISO 9001:2015 / TS 16949

● Maintenance of destructive testing equipment

● Creating quality plans, Visual Aids, Control Plans, Quality Alerts, Process Containment as well as benchmarking techniques as to reduce Warranty Returns, Scrap and Rework

● Assisting in directing QA personnel during new, critical, projects, and material developments

● Root cause investigation and resolution on material disposition

● Implementation of corrective actions, 8D\ 5 whys, auditing for effectiveness, and defect source elimination

● FAI and AIAG PPAP submittals, conducted process FMEAs, implemented Control Plans

● Supplier Coordinator for customers with TS 16949 / AIAG requirements

● Formalized the process to monitor RMA, DMR, Rework and Scrap with trend analysis as a % of sales

● ISO Class 8 Clean Room Environmental qualification, monitoring, and control, for medical-grade projects

● Conducted six sigma studies to provide evidence to top management on methods of improvements, such as eliminating unnecessary operations, and other wastes

● Design of attribute/variable gages to eliminate start up approval waiting time, assisting operators for quick product verification during set-up, in-process, and final. Page 1of 2

Gerardo Arellano

210 S Prospect Ave, Itasca IL 60143



ALLIED DIE CASTING CO., Franklin Park, IL - 2006 to 11/27/07 Quality Engineer

● Assisted in directing 15 inspectors and 2 supervisors

● Creating Control Plans, PFMEA, and Visual Aids

● Corrective Action Request with Root Cause analysis, 5 whys and 8d forms

● Manage internal testing documentation, equipment, and procedures

● Responsible for the in-house calibration capabilities improvement projects

● CMM programming

● PPAPs - AIAG complaint

ROYAL-FAB CO., Bensenville, IL - 2003 to 2006

POP manufacturer, fabricator, and distributor

Owner and President

● General Manager

● Responsible for all customer contact and overseeing shop production.

● Maintenance of equipment such as punch press, break press, rocker arm welder, press welder, mig welding, etc. UNITED DISPLAY CRAFT -1991 to 2002

Quality Assurance Manager/ Safety Director

● Created from ground up a Quality Assurance and Safety departments.

● Formal training on basic inspection equipment and proper utilization of inspection plans such as ANSI/ASQ Z1.4, 2.5 A.Q.L. and applicable industrial standards: ASTM A513, ASTM A109, STI, IFI handbook, etc.

● Conduct capability studies and trouble-shooting analysis to minimize rework costs.

● 40% reduction on warranty returns, through analysis of product returns and implementation of design changes.

● Conducting supplier assessment audits, material review board, design reviews.

● Directing Safety Committee and group leaders enhanced mechanical and/or electronic safety devices to manufacturing equipment, winner of W.C.T.I. safety awards. ITT BELL & GOSSETT - 1982 to 1991

Q.A. Engineer directing one Q.A. supervisor and fifteen floor inspectors 48% reduction of rejected incoming materials through supplier certification/consolidation program, supplier quality assessments, design reviews, statistical process control including capability studies to meet 1.33 Cpk values, JIT manufacturing environment, member of Supplier Certification Board, construction machining and testing of ASME pressure vessels, extensive machining of motor and valve components to a tolerance of .0005” to .00005”. Machining of gray iron, cast brass, aluminum die castings, stainless steel, etc.


ASQ member, Senior Member A.S.Q

A.S.Q. Certified Quality Engineer, Certified Quality Auditor UoI BIS - Root Cause analysis.

DOE I & II, presently taking DOE III (ASQ Chicago/Triton). Reliability Engineering basic, advanced and applications. Page 2of 2

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