Divya Gowdar
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Divya Gowdar Email & Phone Number

Location: Fort Washington, Pennsylvania, United States 13 work roles 2 schools
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Role
Programming Co-Chair
Location
Fort Washington, Pennsylvania, United States
Company size

Who is Divya Gowdar? Overview

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Divya Gowdar is listed as Programming Co-Chair at Women In Bio - Engage. Educate. Empower., a company with 103 employees, based in Fort Washington, Pennsylvania, United States. AeroLeads shows a matched LinkedIn profile for Divya Gowdar.

Divya Gowdar previously worked as Founder and CEO; Quality/Regulatory Consultant at Nubgenix and Visiting Professor at Devry University. Divya Gowdar holds Master'S Degree, Biomedical/Medical Engineering from New Jersey Institute Of Technology.

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About Divya Gowdar

I am a performance-driven leader with a proven track record of extensive industry experience in a regulated environment for medical devices and combination products. Exhibited significant successful contribution in the quality management system, product development lifecycle, risk management, quality compliance, and technical operations. Exemplified sound judgment, decision making, integrity, and critical thinking skills to drive successful and positive results. QUALIFICATIONS• Leadership & Management: Led teams of up to nine (9) Quality Professionals across two (2) teams and managed operating budgets of $400K. Served as representative for the Quality System and reported on the performance of the Quality System to Management with executive responsibility.• Strategic Direction: Implemented Inspection Readiness program to guide regulatory cGxP and other internal Inspections.• Compliance: Coordinated global data-driven compliance activities including Quality Management Review, Inspection Management, Training, Change Controls, Supplier Management and Complaint Management.• Savings: Contributed to $350K worth of total annual business savings by streamlining and implementing Operator Self Inspection program (OSI) for high volume products. • Process Improvement: Implemented 5-S and Lean plant-wide to improve process flow and efficiency by 30%.

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Women In Bio - Engage. Educate. Empower.
Women In Bio - Engage. Educate. Empower.
Programming Co-Chair
Fort Washington, PA, US
Employees
103
AeroLeads page
13 roles

Divya Gowdar work experience

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Founder And Ceo; Quality/Regulatory Consultant

Current

Greater Philadelphia

NubGenix mainly focuses to support start up and mid-size medical device, combination products and pharmaceutical organizations. We provide support from early development through post-market phases. We also assist in designing, establishing and execution of complete Quality Management System (QMS).

Aug 2021 - Present

Visiting Professor

Current

Fort Washington, Pennsylvania

Apr 2016 - Present

Associate Director

Experienced Quality Leader who led the overall compliance of Takeda Global Quality Device and Combination Products (DCP) processes and quality records against changing device and IVD regulations. I was responsible for establishing certification and product licensing, oversight of regulatory labeling for DCP products, and act as the designee of Head of.

Oct 2019 - Jul 2021

Manager, Device Quality Assurance

Exton, Pennsylvania

Established and drove global product quality assurance and operational efficiency by leading compliance activities for devices/combination products including but not limited to batch disposition, internal/external audits, supplier management, management review, and complaints management

Dec 2017 - Sep 2019

Plant Quality Manager

Active participant of the Management Team to develop strategies for QA initiatives in support of divisional business initiatives. Formulate and implement an annual Quality Plan, departmental goals, action plans, and budgets according to Corporate and Departmental priorities.

Apr 2016 - Dec 2017

Manager, Quality Engineering & Investigation

Managed staffing, training, mentoring, and guided four (4) Quality Engineers and five (5) Customer Complaint Technicians to maintain and improve product quality and systems consistent with department and strategic objectives.

Oct 2014 - Mar 2016

Sr. Design Qa Engineer

Represented as a “Quality Lead” to identify and implement the new requirements of quality standards of ISO 14971 – Quality Risk Management of Medical Devices, Collaborated with cross-functional teams and supported qualification and delivery of new products worth $1.0M.

Nov 2012 - Sep 2014

Quality Engineer

Allentown, Pennsylvania Area

Oct 2009 - Oct 2012

Quality Engineer

The Medtech Group Inc

Managed, coached, and supervised daily activities of six (6) quality control inspectors and assigned resources to meet the organization's objectives.

Jan 2009 - Oct 2009

Instrumentation/Quality Engineer

Managed and supervised a team of 3 quality control (QC) inspectors to ensure that the organizational requirements are met.

Jul 2007 - Dec 2008
2 education records

Divya Gowdar education

B.S, Instrumentation Technology

Visveswariah Technological University
FAQ

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What company does Divya Gowdar work for?

Divya Gowdar works for Women In Bio - Engage. Educate. Empower..

What is Divya Gowdar's role at Women In Bio - Engage. Educate. Empower.?

Divya Gowdar is listed as Programming Co-Chair at Women In Bio - Engage. Educate. Empower..

Where is Divya Gowdar based?

Divya Gowdar is based in Fort Washington, Pennsylvania, United States while working with Women In Bio - Engage. Educate. Empower..

What companies has Divya Gowdar worked for?

Divya Gowdar has worked for Women In Bio - Engage. Educate. Empower., Nubgenix, Devry University, Takeda, and Bard Davol.

How can I contact Divya Gowdar?

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What schools did Divya Gowdar attend?

Divya Gowdar holds Master'S Degree, Biomedical/Medical Engineering from New Jersey Institute Of Technology.

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