Surya S.

Development Quality Engineer @Abbott

Plano, TX, US

Lead identification of essential outputs and generate Essential Output reports, accountable for completion of labeling verification activities and labeling verification reports, work with design engineering in the completion of customer/system/product requirements, work with design engineering in the completion of product verification and validation. • DHF content completion, integrity and regulatory & standards compliance, collaborative communication resolving gaps, complete document change request reviews in a timely and objective manner, identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. • Update existing R&D/Quality processes for maintenance/creation of design history files and other supporting documentation to be alignment with the latest EU MDR regulations • Incorporate changes from updated EU MDR guidelines into Design Control procedure and Device Master record. Made sure all the clauses from EUMDR Gap assessment were met in the local procedures.• Developing and creating procedures for incoming in process and final inspection of components and finished goods• Monitors manufacturing of assigned product assuring compliance with Device Master Record (DMR) and quality system requirement and assuring complete and correct Device History Files (DHF) are maintained

Maharishi Markandeshwar University,Sadopur

Bachelor of Engineering, Computational Science

Maharishi Markandeshwar (Deemed to be University) Official

Bachelor of Technology - BTech, Computer Science

San José State University

Master's degree, Engineering/Industrial Management

San José State University

Master of Science, Engineering/Industrial Management