EMPLOYMENT OBJECTIVE:

Product, Process, and Systems Quality Engineering

Team management and seasoned leadership in aerospace manufacturing quality assurance and quality systems, successfully meeting company and customer goals. Technical expertise in quality engineering, quality planning, auditing, change management, risk management, documentation, corrective actions resolution, training, and utilizing aerospace, medical device, automotive, and end user protocols for the quality management system.

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WORK EXPERIENCE, EMPLOYMENT ACCOMPLISHMENTS: Over thirty-eight years in the engineering, manufacturing, leadership, and management areas of Quality Assurance.

Quality Systems implementation and technical writer for system development, PFMEA risk management, new product development, comprehensive procedures development, and documentation standardization. Leadership in certification body, customer, and supplier audits, internal quality auditing, and resolution of corrective and preventive actions. Supplier development and reporting. Advanced quality planning leader, Management Representative, trainer, and departmental supervision. Implemented QMS and maintained AS 9100D:2016 (aerospace),

ISO 13485:2016/QSR medical device), ISO 9001: 2015, IATF (TS) 16949:2016 (automotive) standards for multiple companies.

Effective results and process improvements.

INDUSTRIES SERVED, QUALITY ASSURANCE: aerospace, medical device, assembly, automotive, commercial, CNC milling and CNC lathe production, intricate metal stamping, metals fabrication, tool and die inspection, passivation, thermoplastic and thermoset molding.

SPECIALIZED SKILLS: Supervisory management and team leadership in close tolerance manufacturing and assembly facilities, with auditing, improvements, and effective internal, customer, and supplier communication. Proficient in Epicor, Trackwise, SAP, Minitab, Microsoft Office and Visio applications, use of all inspection instruments, and extensive employee training capability. Document control management, data analysis, process mapping, and test method validation activity (TMV) for product realization. Full implementation of APQP, including Control Plans, PFMEAs, MSA, AS9102 First Article/AS 9145 PPAP, real-time SPC, gage calibration, gage design. Extensive application of Total Quality Management (TQM) principles (six sigma, 5S+1, Kaizen, cost of quality). Excellent communication and interpersonal skills. Team leader and a self-starter.

EMPLOYERS:

Montevideo Technologies/MTI Pleasant Prairie WI 9/2019-11/2019 Product Quality Engineer

Contracted to improve process engineering for Aerospace assemblies.

Performing AS9102 FAIRs, auditing supplier FAIRs, rebuilding compliance records, improving the QMS

and improving documentation and change management.

Flex Medical Buffalo Grove IL 2/2019-9/2019 Manufacturing Quality Engineer

Contract focus on operations and manufacturing quality process engineering improvements.

Responsibilities of internal auditing, systems engineering, customer corrective actions, technical writing, change management, and training.

Montana Metal Products Des Plaines IL, 4/2018-10/2018 Senior Quality Engineer

Contract focus on customer corrective actions for aerospace components and assemblies.

Responsibilities for successfully resolving a multiple customer corrective actions backlog.

Implemented new quality planning, AS 9102 FAIRs, process improvement, and change management.

Dexter Magnetic Technologies, Elk Grove Village IL 7/2013-4/2018

Senior Quality Engineer, Quality department Co-Manager.

Permanent magnet assemblies and process design for aerospace, defense, medical, commercial, oil + gas.

Organizational layoff 3/2018.

Leadership in QMS surveillance audits, customer audits, and internal audits. Technical writing and implementation of QMS for AS 9100D (2016) and ISO 13485:2016 for successful BSI certifications.

Advanced quality planning, risk management, and coordinating team reviews for new and existing products, machinery installation qualifications. Requirements flow down including process mapping, utilizing lean manufacturing principles, QMS improvement, training.

Customer and supplier liaison for quality and order compliance, initiating and effectively resolving corrective actions (customer, supplier, audit, internal, preventive).

Leader for resolution of MRB on discrepant materials and customer returns, resolving process errors through engineering and documentation changes.

Omron Automotive Electronics, St. Charles IL 3/2012-9/2012 Supplier Quality Engineer

Tier 1 manufacturer of engine electronics relay assemblies. Layoff.

Implemented supplier improvement via corrective actions, containment, and metrics reporting.

ISIR/PPAP reviews with TS 16949 focus, Part Process Validation, supplier QMS improvement assistance per TS requirements. Close focus on injection molded and stamping products.

Supplier development, auditing, component performance, change control, and product management.

Phillips Medisize Corporation, Menomonie, WI 11/2011-1/2012 Quality Systems Engineer

Class III medical device manufacturer of assemblies and injection molded products.

Standardized and implemented multiple Document Control processes into an effective change management system for compliance with FDA and ISO 13485 requirements.

Facilitated an effective integration of procedures, work instructions, and records management.

Contract completed with training and assessment reporting for 90 employees.

SIC Lazaro US, Inc., Milwaukee WI 6/2011-10/2011 Quality Systems Engineer

Multi-national company’s North American start up site producing elevator, escalator,

and heavy industry counterweights. Successfully completed a 14-week contract assignment.

Produced ISIR/PPAPs, implemented site compliance with ISO 9001:2008 and coordinated its quality system and manufacturing processes with industry best practices.

Initiated and implemented comprehensive procedures and work instructions that successfully underwent full ISO compliance audits by three of its major customers.

Trained its personnel and Quality Lead person toward its 2012 QMS certification and registration.

bioMerieux Industry, Inc. Lombard IL 7/2010-5/2011 Quality Engineer

Manufacturer of prepared culture media for microbiological, environmental, and laboratory diagnostics. Contract completed with the alleviation of QA workloads and product transfers.

Investigated and resolved customer complaints, corrective and preventative actions (Trackwise).

Coordinated Risk Analysis for world-wide launch of transferred products to Chicago facility.

Completed test method validations (TMVs) for new instrumentation, raw material properties and component qualifications, focusing on supplied injection molded products.

Led supplier corrective actions.

Inland Midwest Corporation Chicago IL 1/2008-7/2010 Senior Quality Engineer, Supervisor

Orthopedic components and implants manufacturer using CNC mills, CNC lathes, and diverse metals for medical devices. Accepted offer from bioMereiux.

Class III Product and Process Validation leader, implemented and completed test method validations (TMV) at all stages of manufacturing: linear measurements, weld verifications, material properties.

Implemented and completed process validations with Installation, Operational, and Performance qualification activities for FDA and customer compliance.

QMS improvement; ISO 13485 and 21 CFR Part 820 system maintenance and three successful ISO 13485 registration audits.

Implemented real-time SPC and managed gage calibration.

EDUCATION:

Elgin Community College, Elgin IL. to 1998 with 30 semester hours, 3.5 grade average.

Engineering-related, ISO systems, and management curricula.

The University of Chicago concurrent with The School of the Art Institute of Chicago,

1970-1973, fine arts painting and printmaking, communications, and art history.

Dundee Community High School, Carpentersville IL 1970.

Member, National Honor Society, National Merit Scholarship Semi-Finalist.

Member, American Society for Quality since 1989.

Certified Quality Engineer, Certified Quality Auditor,

Certified Quality Technician, Certified Mechanical Inspector.

PROFESSIONAL REFERENCES WILL BE PROVIDED ON REQUEST.

Statement of Intent: My years of responsible professional performance and quality engineering management produced valued employment to each organization by meeting their needs: to improve their quality focus while maintaining their market position, to exceed customer expectations and to prosper in the years to come.

The hallmarks of my work ethic include leadership, team involvement, accuracy, and enthusiasm brought to the workplace.

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