HARINI NAND KISHORE

***** ********* ******,********,**-92563 Phone: 269-***-**** adch5i@r.postjobfree.com

OBJECTIVE

Proactive and reliable team member with strong leadership capabilities; proven commitment to learning new technologies and shouldering new responsibilities. Strong understanding of FDA medical device requirements and Quality system standards. Exceptional communication and interpersonal talents backed by ability to concisely convey highly technical concepts to a wide variety of skill levels

WORK EXPERIENCE

May 2018-present: Extrusion Quality Engineer, Abbott Vascular, Temecula, CA

Duties:

Responsible for transferring extrusion equipment from one Abbott site to another and prepare final installation of the equipment post transfer and contributed to the development and execution of IQ/OQ/PQ, Facilities validations that led to a successful line transfer from Abbott Vascular (Temecula) to Abbott Vascular (Santa Clara)

November 2016-Feb 2018: Manufacturing Engineer, Boston Scientific, San Jose, CA

Duties:

Developed and executed Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification PQ) protocols/reports, Test method validation (Attribute), Process characterization and Master validation plan (MVP), for optical fiber components across urology department

May 2016-November 2016: Quality engineer, Terumo Medical Corporation, Elkton, MD

Duties:

Authored and executed IQ, OQ, PQ and performed Test Method Validation

Aug 2013–December 2015: Teaching Assistant, Murray State University, Murray, KY

Duties:

Supervised several undergraduates by organizing responsibilities, designing and coordinating experiments, and training them in laboratory techniques, instrumentation, procedures, and daily tasks by designing lectures, leading discussions, demonstrating procedures, fielding questions, and grading student lab reports

EDUCATION

Jan 2019-Present : Master of Business Administration

California Institute of Advanced management, Alhambra, CA

Aug 2013-Dec 2015 : Masters in Chemical Manufacturing and Management

Murray State University, Murray, KY

TECHNICAL PROFICIENCY

Understanding of 21 CFR Part 820, ISO 13485 and ISO 14971

Familiar with Microsoft office suite, Statistical analysis software (Minitab, JMP), AGILE, Viewpoint and Windchill

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