Sigma Operation Services-SOS Contract services primarily for the Medical Device contract suppliers. Specializing in Quality, ISO 13485 and FDA Compliance, Lean Six Sigma, Validation, Measurement Solutions----------------------------------------------------------------------------------------SJS Management Asssociates, Inc., Lehigh Acres, FloridaQuality / Management Consultant- responsible for assisting primarily Medical Device companies with ISO 13485 and FDA compliance, measurement systems, validations, Lean-Sigma / DMAIC, SPC, MSA, Project Management, Product Launch, etc…-----------------------------------------------------------------------------------------Youngquist Medical/ Innovative Medical, Fort Myers, FloridaQuality Assurance Regulatory Manager- responsible for developing the quality system ISO 9001 & 13485, 21 CFR Part 820 FDA compliance, training all personnel, auditing, quoting, order entry, internal sales----------------------------------------------------------------------------------------Medtronic, Spinal and Biologics, Warsaw, IndianaLargest international business of spinal and biologic medical devices/systemsManager of Quality Engineering- responsible for quality engineering, metrology,validations, new products, statistics, inspection automation, ISO 13485, 21 CFR Part 820 FDA compliance/ PMA submissions and Puerto Rico transfers.Senior Quality Engineer- responsible for gauge design, quality plans, product complaints, Calibration procedures, auditing, statistical process control and new product introductions.•Recognized in a Global Technical Forum for designing a proprietary gauge system to measure a unique patented thread.----------------------------------------------------------------------------------------GE Aircraft Engines, Cincinnati, OhioLargest international manufacturer of aircraft engines for the military, commercial use.Specialties: Lean Sigma/ DMAIC, SPC, Internal Sales, Metrology, Project Management, Management/ Supervision, ISO 13485 MDD,