DAVID ABOITE ZAYAS
INDUSTRIAL ENGINEER / Quality and Productivity
664-***-****/ email@example.com / USA Visa Active
PROFILE OF QUALIFICATIONS
Experienced as Senior Quality Assurance Engineer; proactive, Interdisciplinary and dynamic with a demonstrated experience of working in Medical Device and Aerospace Industry (Skilled in ISO-13485 standard & U.S. FDA Part 820 regulation, QMS, ISO 9000/AS9100). Leadership (Ability to influence and lead others) Negotiation, Initiative and attention to detail to coordinate multiple projects (Multitasking) effectively under pressure and completing them on time. Results driven, analytical and diplomatic professional able to cooperate and work across sites at all levels or independently to accomplish goals and customer needs (Team player attitude). Ability to identify opportunities for improvement. Enthusiastic and positive behavior. Planning, Organization & Communication Skills to solve problems with statistical analysis.
To integrate and collaborate as a team member in a dynamic challenging work environment in a leadership position, Analyzing, solving problems and managing company resources that allow me to apply my knowledge and skills to achieve the objectives (VOB) and customer needs (VOC), exceeding expectations through teamwork and continuous improvement.
NYPRO, JABIL Sr. NPI Quality Assurance Engineer Feb-2016 – Current
QE with Recognition Received from Jabil Corporative.
Responsible in Quality Assurance for Transference of Assembly Process of 2 projects: Optical Medical Devices Class III. Contact direct with customer to perform all Quality/Manufacturing procedures; Implementation of MVP, AQP, Quality Agreement. Creation of IQ (Test equipment) and TMV (Gage RR, Visual and Automated Inspection), Work instructions and visual aid for test equipment: USON, software tester, CTS Leak Tester, Chatillon, Quality inspections (in-process, metrology, packaging) and certifications in CTQ inspections. Support to customer to determine Quality requirements: Visual, functional, dimensional and packaging tests and working along Engineering and Automatization department to determine strategies for FAT, SAT, IQ, ES (DOE), OQ and PQ validations, giving coaching and as Quality approval.
Support for Design verification and improvements with customers to determine specifications (CTQ’s, CQA), PFMEA, Risk Assessment, Control Plan, SPC, sampling Plans.
Execution of FAT’s 1) Equipment Automatized in Mikron Denver, 2) Tray Sealer in Belco Facility at California and 3) Software Tester (Quality Functional test) in ATS Toronto.
Responsible to implement corrective and preventive actions to respond Customer Complaints, CAPA’s and NCMR’s, MRB, internal and external audits (investigations and presentation of results). Update of PFMEA and control plan in process assembly.
Supervision of 1 QE, 1 Quality Technician, 3 Quality Auditor and 6 QC inspectors: Training and development.
Implementation of sampling plans and SPC for all variable data (critical dimensions).
Responsible to Communicate weekly with customer to follow up Quality issues.
FLEX MEDICAL Sr. NPI Quality Assurance Engineer Jun-2014 – Feb-2016
Responsible in Quality Assurance for Transference of Process of AMO (Abbott Medical Optics) from Puerto Rico to Tijuana.
Support to Quality Manager to lead and provide support in all activities (TMV’s, acceptance criteria, PQ, support on CAPAS, Complaints, NCMR’s) performed by Quality Engineers and also with follow up of Quality Metrics (NC, CAPA, Complaints, Quality Incidents).
Responsible in the generation of PQ validation (execution), TMV’s (standard inspections) and update of Quality procedures applicable for new projects with the customer (new PN, New molds) and also working along Engineering department for IQ and OQ validation, giving coaching and as Quality approval.
Responsible of Quality Approval of ECR, MVP, IQ, OQ, PQ, TMV, inspection and manufacturing procedures, calibration of equipment (La mesa and Otay facility).
Responsible of lead the team of CFT (Engineering, production, maintenance) to follow up to make the Quality Assessment, determine root cause related with Customer complaints, process and supplier NCMR’s, CAPA (Coordinator) and PA; validating the effectiveness of the implementation of corrective and preventive actions.
Leader along with Quality Supervisor implementing corrective actions to reduce MRB.
In charge to lead along with Eng. the transference of Ashville-Buf. G. molding project.
Responsible to Communicate weekly with customer to follow up Quality issues.
In charge in improve of Quality procedures, Quality Plans, PFMEA and Risk Management.
Supervision and training of quality inspectors (Quality Inspections, standards, process).
Participate on external audits with customer and also internal audits.
ZODIAC AEROSPACE Quality Assurance Engineer II Jan 2014 – Jun 2014
Supervision and training of Quality Inspectors (6) and Quality Supervisor (1).
Representative of Quality in transference of process of AIRBUS A380 process traveling to EUA, establishing acceptance criteria of the product, based on Airbus quality procedures.
Leader of Area to investigate, coordinate and implement the corrective/preventive actions to Customer Complaints, NCMR’s and SCARs to communicate with customers.
SMITHS MEDICAL Quality Assurance Engineer I Nov 2012 –Jan 2014
Responsible to implement corrective and preventive actions to respond Customer Complaints, NCR’s (investigations and presentation of results).
Maintained and reduce the % requested in Quality Metrics (Complaints, NCR’s, Deviations, MRB) aligned with business and customer needs. Leader in Process Audits implementing corrective actions and improvements on assembly and extrusion lines.
Supervision of 10 Quality Inspectors (1st and 2nd shift).
Author of analysis statistical reports and performed 8 D’s, 5 Whys, FMEA, and Cause & Effect to determine tendencies and recommended corrective actions and changes in manufacturing process and for solving issues related with extrusion lines (corrugated tube (pediatric), smooth tubing, catheter) and molding machines (connectors).
Participate in a project to reduce from 40 % scrap to 20 % scrap ($15000 dlls) related with resin used on corrugated tube implementing quality improvements (acceptance criteria).
Implementation of test method inspection process in extrusion and molding process.
Reduced sampling plans for all tubing inspection (8 extrusion lines).
Lead of the Area in MRB reducing in 50% of nonconformance material ($45,000 dlls).
HANSA LANGUAGE CENTER. Toronto Canada Jul 2012 – Sept 2012
English course advanced-Level. Travel Personnel Experience
KIMBERLY CLARK (Avent) Quality Assurance Engineer I Dec 2010 – Jun 2012
Receiving ONE-KC recognition by the corporative.
In charge validating equipment and test methods (IQ/OQ/PQ/TMV) and development Gap Analysis, Cause & Effect Matrix, Control Plan, SIPOC and FMEA on MVP project.
Leader in TJ of Insourcing Project Molding coordinating work groups and working along with R&D and Engineering; validating and performing protocols & completion reports and quality testing with new components such as: Mandrel, Finger Plate, Snap Cap, Cap Case, Manifold, Retainer Tube, Lever Arm, Dial Cam; succeeding in reduced in the cost of I-Flow’s plastic molded components. (Reduction of 200,000 dlls in 6 months).Conducted analysis and inspection with measurement equipment working along Incoming Inspection (based on drawings and specifications) of new components plastics by cavities as support for Nogales Facility to improve the Quality of the parts (cosmetic issues, functional issues)
Responsible in Customer complaints, NCR’s to solve problems in processes such as: High and Low Pump Flow, Select-A-Flow, PCA, and Catheter, giving support and training to manufacturing lines with the application of quality controls and update Quality Procedures.
Level of English (Spoken 90% - Reading 100% - Writing 95%).
BS Degree in Industrial Engineering; Instituto Tecnologico de Los Mochis, Sinaloa 2005-2009 / Graduated with honors, Professional ID #6549124.
Quality System: FDA CFR 820/ISO 13485, ISO 9000, AS 9100, ISO 14000, Auditing.
Lean Six Sigma Tools: PFMEA, Control Plan, Process Capability, SPC, MSA, DOE, Hypothesis Testing.
Lean Manufacturing Tools: 8D, 5 Why’s, Ishikawa, TPM, Process map, Kaizen, VSM, SIPOC, C&E
Software: Minitab, AutoCAD, Stat Graphics, Agile, SAP, Oracle, Baan system, Visio, MS Office, Project.
Training: FDA regulatory requirements of PMA class III, Tress System, Scientific Molding, Green Belt, Minitab, Lean Manufacturing, ISO 9000/14000, AS9100, AutoCAD 2D and 3D, Process Validation (IQ, OQ, PQ, TMV), Statistical and Sampling Plans, Root Cause Analysis.
Machine Skills: Molding, Extrusion, Optical comparator, Microscope, Vernier, Micrometer, Torque, Chatillon, High Gage, Medical, Branson, USON, FFS, Band Sealer, R& F, Tray sealer.