Lupita Roberts Email & Phone Number

Cleveland, Oh, Us

Strongsville, Ohio, Us

Mentor, Ohio, Us

-Management Representative -Certified Lead Auditor for AS9100D and ISO9001:2015-Quality Systems Specialist-PPAP, FAI and NPI specialist-Non-Destructive Test (NDT) trainer coordinator. -New Product Introduction, Change Manager, Risk Assessment Quality Representative-Corrective Action (Internal and External)-Calibration Coordinator-Regulatory affairs compliance officer and liason for RoHS, REACh and Conflict Minerals.

-AS9100D Certified lead Auditor-Upgrade the QMS to meet the new requirements for AS9100D Aerospace.-Successfully completed certification for two companies on AS9100D and ISO:9001:2015

New York, Ny, Us

- Qualified Director of Quality with over 20 years experience in the electronics manufacturing industry and medical instrumentation.-Management of Inspection, Test, Engineering and Quality departments.- As Management Representative I developed and implemented the QMS to meet the requirements of ISO 9001, ISO 13485 and most recently the foundation to 21CFR820 for FDA and ISO 14000 for environmental.- Hands on experience on PPA, FMEA, Control Plan development, review and submissions.- Trainer on Electronic Manufacturing Standards based on IPC.- Mentor, advisor and trainer for all employees on IPC Workmanship Standards. - Regulatory affairs compliance officer and liason for UL, TUV, CSA. ETL, NAFTA, ITAR, RoHS, REACH, and Conflict Minerals.- Lead Auditor for ISO 9001, ISO 13485, and diverse Customer Requirements.- Regulatory compliance of medical devices for Asia and Europe. - ROI studies on the purchase of capital equipment.- Winner of Lean-Six Sigma projects with partnership with Customer programs to improve quality and reduce cost.- Planning and development of data collection tools and measurables.-Implementation of company's scorecard to benchmark company goals against industry standards.

-Quality Engineer for digital and analog instrumentation and control systems for GM cars such as ABS, Air conditioning, Cd player, drivers gage panel, etc.-Corrective Action management from receipt to implementation and follow-up.-Implemented First Article inspection for all steps of the process.-Introduction of GM Targets for Excellence procedures.-Participated on Shainin Quality Training in Michigan. This training was the basis for Quality Improvement projects that I was fortunate to participate in some of them. -Promoted to General Manager after five years of employment to improve scheduling and production planning and quality.

Master (No Diploma), Industrial Engineering

Engineer, Electronic And Communication; Control Systems