Engineer Quality

Summary

Over * years of experience with ISO *****, ISO 14971 QMS practices in class II and class III medical devices.

Strong knowledge of investment casting, injection molding, rapid prototyping and electronic device assembly and testing processes.

Working knowledge of Statistical Process Control, Statistical Quality Control, Design of Experiments-DOE (i.e. fractional factorial, placket-burman, and response surface methodology) Gage Repeatability & Reproducibility (GR&R), Analysis of Variance (ANOVA), distribution analysis, statistical significance tests, process capability analysis and regression analysis.

8 Disciplines (8D), 5 why analysis, engineering change control, GD&T standard ASME Y14.41-2003.

Educated in Advanced Product Quality Planning-APQP, Production Part Approval Process-PPAP through AIAG manuals.

Coordinated and managed inspection setup and inspection plans for conducting first articles inspections and incoming inspection activities. Knowledge of IPC 610 standard.

Hands on experience with Pilgrim-Smart solve, ecentral-PLM system, QAD ERP system, Minitab 16.0, Design Experts, Minitab 16.0, Stat-Graphics, and JMP.

Professional Experience

Physio-Control, A division of Medtronic Inc. Seattle, WA Oct 08 – Present

Operations Quality Engineer

Consent decree remediation - CAPA and SCAR:

Spearheaded CAPA projects affecting product and process to address quality issues using DMAIC methodologies for an assigned defibrillator product line.

Supported line down/Response team efforts to investigate major quality issues, developed containment plans and implemented interim and long-term resolutions in support of recovery efforts to resume manufacturing operations.

Supported timely resolution of supplied part issues by participating in identification of affected population, containment planning, supplier root-cause analyses and deployment of corrective and preventive actions.

Planned, reviewed and approved rework and disassembly activities of the defective contained material in support of salvage and recovery of stranded inventory.

Performed process mapping, clarified roles, and responsibilities and establish process health metrics for product hold/containment process, risk analysis and assessment process and CAPA process for a class III medical device.

Verifications and Validations:

Planned, prepared, reviewed, and approved manufacturing assembly process and automated test system (integrated hardware and software) validations and verifications, service assembly and test process validations for preventive maintenance and post-repair quality assurance for Class III medical devices.

Performed risk analysis to determine appropriate validation class to support the sample size selection.

Ensured all the requirements defined in specification are implemented and exercised through traceability matrix.

Developed testing/validation protocols for class III medical device to ascertain the absence of a quality issue on a supplied part in support of defending a product recall.

Sandvik Medical Solutions, Oregon City, OR Mar 08 – Oct 08

Project Quality Engineer

Lead standardization efforts on process control parameters for manufacturing process phases namely tool designing, tool verifications/layouts, wax injection molding, shell preparation, de-waxing and burnout process, induction melting, casting, shell removal, cutoff, finishing, straightening, welding, inspections, core removal, heat treatment, machining and hipping for investment casting process.

Prepared PPAP packages in support of new product development for the orthopedic implants.

Developed and implemented SPC program for investment casting processes.

Qualified and released injection molding tools, inspection gages, and methods with extensive use of tool dimensional layouts, Gage R and R, process capability studies and first article inspection reports.

PML Microbiological, Wilsonville, OR Mar 07 – March 08

Industrial Engineer

Developed and implemented process quality metrics and analyzed defect data to trend and drive manufacturing improvements.

Lead planning, investigations, and execution for manufacturing process improvements.

Engaged with suppliers on specific quality issues, developed process controls and FMEA's to ensure that critical to quality characteristics are monitored and controlled to support cost reduction initiatives.

Negotiated quality deliverables with product suppliers to clearly establish expectations and define responsibilities.

Chrome-Plus International Inc., Wichita, KS May 06 – March 07

Quality Engineer (Master’s Internship)

Masters Project (Six-Sigma: A tool for achieving “Nadcap” program requirements):

Spearheaded Integration of Six Sigma DMAIC approach in to Quality Management Systems at chrome plus international.

Achieved a Cp=Cpk of 1.33 from a Cp = 0.345 & Cpk = 0.155 in six months duration. Tasks included analysis of variation from measurement systems, Defining CTC, CTQ parameters for the aircraft landing gears, implementing statistical process control charts in a high volume-high mix production environment and optimization of the hard chrome plating process using DOE techniques namely Screening and Response Surface Methodology.

Wichita State University–National Institute for Aviation Research, Wichita, KS. May 05 – May 06

Project Lead

Developed test plans for composite material testing program encompassing activities of test set up, testing execution, inspection set up/ plans and calculation of material properties (i.e. tensile, compressive, bearing, creep strength) for composite test coupons.

Deployed inspection plans for composite test specimens using precision measuring equipment’s such as calipers, dial gauges, bevel comparators, micrometers, CMM and FARO Arm.

Performed Measurement System Analysis (MSA) to support the selection and adequacy determination of measurement systems for composite test specimens.

Identified and analyzed various sources of variation in the grinding process of composite specimen with factorial experimentation technique of DOE affecting the dimensional variability and surface finish.

Education

Master’s in Industrial Engineering (March 2007)

Bachelor of Mechanical Engineering (June 2003)

Certifications

Certified Quality Improvement Associate by American Society for Quality (Certification No. 4299).

Certified Six Sigma Green Belt by American Society for Quality (Certification No. 543).

Certified Quality Engineer by American Society for Quality (Certification No. 52989).

Certified Six Sigma Black Belt by American Society for Quality (Certification No. 9323).

Certified Manufacturing Process and Test Method Qualification and Validation (i.e. IQ, OQ, and PQ as per GHTF /SG3/N99) by Medtronic.

Certified Corrective and Preventive Actions - CAPA Specialist as per GHTF SG3 (PD)/N18R8 by Medtronic.

Publication:

Title “Six-sigma: A Tool for Archiving "Nadcap" Requirements”, Issue 7, Part 2 of Report, Publisher Wichita State University, Department of Industrial and Manufacturing Engineering, 2007

Recognitions

Operational optimizer (2010) at Physio-Control: An individual or team who initiates efficient and measurable process improvements to fuel innovation. Able to remove inefficiencies with velocity and passion. Drives change through collaboration and the power of Team.

Professional affiliation

Member of ASQ, Section 0606, Seattle, WA and Section 0607, Portland, OR

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