Jobby Mathai Email & Phone Number

Irving, Tx

Plano, Texas

-Management Representative for GE Ambulatory (APS) Design Sites: Plano TX and Hillsboro OR.-Responsible for support and execution of Quality Management Review/Metrics, Internal Audits, Design Controls/Risk Management, Complaint Handling/Investigations, Supplier Quality, Field Actions, Regulatory determinations and Training across APS Sites.-Serve as independent QMS Internal Auditor for GE Healthcare IT FDA Registered Sites.-Worked with GE Healthcare IT cross-functional experts to create CAPA/Investigations training and guidance. Guidance currently used across GE Healthcare IT to drive consistency and thoroughness of records.-Member of GE Healthcare-wide QMS Simplification Team responsible for creation and implementation of an ISO9001 based QMS for non-registered sites.-Owner of 2014 APS Product Quality Initiative, which resulted in a deep-dive product quality investigation and greater than 50% reduction in open APS Investigations and CAPAs.

Plano, Texas

-Responsible for implementation of the Site Quality Management System for GE Healthcare acquired business, compliant to GE Healthcare Global Quality System and US FDA Medical Device Regulations.-Responsible for CAPA program, including creation of a site-level CAPA Review Board and Nonconformance/Trending Boards.-Responsible for Plano Site Internal Audit program.-Responsible for Site and Global quality improvement/simplification initiatives through Lean Six Sigma and Kaizen-Quality interface for internal Service and Engineering functions and external Global Quality functions.

Flower Mound, Tx

-Chosen by top management to champion a Quality System Improvement Plan as a site representative in creation and implementation of a Corporate Quality System. Created and successfully implemented Divisional Standard Operating procedures and Work Instructions for Complaint Handling, Medical Device Reporting, Product Field Actions and Internal Auditing across two Endoscopy sites.-Acted as a Regulatory representative on Design project teams which included R&D, Quality Engineering, Marketing, Operations and Integration. Responsibilities included Pre-Market submission consideration, input and reviews of FMEAs, review of Verification/Validation Protocols and Test Reports, Literature Review for labeling and marketing materials and Technical File input.-Responsible for coordinating and facilitating quality system audits conducted by External Auditors (FDA, ISO Notified Body, etc.) Responsibilities included management of the Audit War Room.

Flower Mound, Tx

-Functioned as independent reviewer of design activities and supported design transfer through execution of a quality plan for new generation products.-Conducted root cause investigations and initiated corrective/preventive actions for complaints, nonconforming product reports and CAPAs.-Managed team of 3 Quality Control Inspectors focused on incoming inspection, final inspection and process improvements.