RICHARD D. JOHNSON

**** ******** *****

Macedonia, OH 44056

Telephone: 440-***-****

adt2k5@r.postjobfree.com

CAREER SUMMARY

I am an accomplished Systems and Quality Engineer with a strong background in risk management, standards and regulatory requirements. I am lean and Six Sigma oriented with leadership and management experience. I am interested in opportunities that include but are not limited to: auditing, risk management, continuous improvement, and a focus on quality management.

EXPERIENCE

NOVEMBER 2022-PRESENT

MULTIWING – MIDDLEFIELD, OHIO

Quality Engineer – Consultant

Initiating and expediting problem solving and corrective action reports

Instituting the Toyota Production System to increase metrics geared towards safety, quality, delivery and cost

Improvements in the final inspection process to assist in the lowering of warranty acceptances

Competency audits

ISO 9001 review while clearing previous non-conformances

Coordination with design engineering with product failures identified within the competency audits

FEBRUARY 2020 – OCTOBER 2022

EDWARDS VACUUM – SOLON, OHIO

Senior Quality Engineer

ISO 9001 certified auditor through Lloyds Register

Support internal and external audit preparation and follow-up including but not limited to ISO 9001, ISO 13485 and ISO 27001

Support and expedite the flow of work and materials within or between Production, Quality and Engineering Departments.

Develop and conduct training activities and plans

Coordinate, support and maintain activities and records for Service Customer Complaints (SCC’s),

Initiate and conduct Corrective and Preventative Actions (CAPA’s), deficiency and engineering investigations

Identify and support quality processes for trending, compile data, and prepare reports pertaining to Engineering, Quality, and Regulatory activities.

Support the creation, review, distribution and control of quality system documentation.

Support the maintenance and storage of controlled and quality system documentation.

Review all quality support and risk documentation for accuracy and completeness as needed.

AUGUST 2018 – FEBRUARY 2020

NATIONAL BIOLOGICAL – BEACHWOOD, OHIO

Quality Engineer

Perform Installation Qualifications

Perform internal competency audits

Maintain ISO 13485 certification

Assist Engineering in verification of performance for UVA and UVB therapeutic devices

Maintain and continue training records

APRIL 2012 – AUGUST 2018

PHILIPS HEALTHCARE – HIGHLAND HEIGHTS, OHIO

Systems Engineer/Risk Manager/Quality and Regulatory Complaint Handling Unit - Responsibilities included:

Certification lead for SPECT, PET/CT, MR modalities

Safety testing and inspection toward IEC 60601 family standards

Detailed background of compliance with ISO 14971 for risk management

Risk manager of all SPECT and PET/CT systems, legacy and forward production

Internal auditor for quality management systems (21 CFR Part 820 - Medical Device Quality System Regulations (QSR), ISO 13485 and ISO 9001)

Maintaining and developing risk management files, determine risk for new and pre-existing defects, lead technical reviews and risk assessment team meetings

Leader of post-market complaint solutions to determine severity and probability of occurrence

Six Sigma - Green Belt certified

Skilled user of Agile, Sharepoint, Clearquest and TrackWise programs

AUGUST 2009 – APRIL 2012

INTERTEK TESTING SERVICES N.A. INC. (ETL), TWINSBURG, OHIO

SENIOR PROJECT ENGINEER/QUALITY SUPERVISOR - Responsibilities included:

Project management, scheduling and planning

ETL and IEC certification of medical, industrial, home appliance, lighting, electrical/software systems and component assemblies.

Inspection and testing for compliance to safety standards (UL, CSA, IEC, ISO)

Equipment calibration and verification

Reviewer for Medical, Measurement, and Industrial standard categories

Standard/Local Operating Procedure (SOP/LOP) development and implementation

Provide training to current and new employees on standard updates

Audit preparation and development of post-audit Corrective Actions Requests (CARs)

Qualified Internal Auditor for ISO 9000, ISO 9001, ISO 14971 standards

MAY 2008 – AUGUST 2009

KICHLER LIGHTING, INDEPENDENCE, OHIO

PRODUCT CERTIFICATION MANAGER – Responsibilities included:

Certification of indoor/outdoor lighting fixtures

Managed four direct reports

LED, halogen, fluorescent and incandescent research

Safety testing for heat, dielectric, weather, loading and abnormal operation compliance

Budget and financial planning

Troubleshooting electrical designs and mechanical failures

JULY 2006 - MAY 2008

INTERTEK TESTING SERVICES N.A. INC. (ETL), TWINSBURG, OHIO

PROJECT ENGINEER/QUALITY SUPERVISOR - Responsibilities included:

ETL and IEC certification of medical, industrial, home appliance, lighting, food service, and electrical/software systems and component assemblies.

Inspection and testing for compliance to safety standards (UL, CSA, IEC, ISO)

Equipment Calibration and verification

Standard/Local Operating Procedure (SOP/LOP) development and implementation

Provided training to current and new employees on standard updates

Audit preparation and development of post-audit Corrective Actions Requests (CARs)

EDUCATION

AUGUST 2009 –JANUARY 2011, MBA

UNIVERSITY OF PHOENIX, Online

Major – Masters of Business Administration

Operations management

Budgeting and project planning

Human resources and team building abilities

Economics and accounting

Strategic planning

SEPTEMBER 2002 – JUNE 2006, BSEE

OHIO UNIVERSITY, Athens, Ohio

Major – Electrical Engineering

Communications and Systems Engineering

Senior Project: G.U.I. development for data acquisition through LabVIEW

Micro/Nano fabrication of Semiconductors

PC skills: Programming in C/C++/Visual Basic, LabView, Word, Excel, PowerPoint, Matlab

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