Quality/ Regulatory/ Clinical affairs in medical device industry

Pinky Tiwari

*** * ******* ****, ****** Lake, Indiana, 46590

Email: **************@*****.***, M: 860-***-****

SUMMARY OF QUALIFICATIONS

Quality Engineering professional with excellent knowledge of Quality Management System, Quality Tools, FDA Regulations (21CFR820), Product Development, DHF, Supply Chain Management and Post Market Surveillance.

Master in Medical Device Quality Management (MDQM) from Grace College, Warsaw, IN with Three year of Quality Engineering and Risk Analysis Experience.

Active member of ASQ and preparing for Certified Quality Engineer Certification (CQE).

Experienced in Product Development, Design Control and DHF.

Experienced in Clinical Writing and DHF Remediation.

Excellent Knowledge of Root Cause Analysis and CAPA.

Ability to perform statistical analysis using Minitab.

Excellent Knowledge of Lean Six Sigma Methodology.

Expertise in Windows Operating system, MS Office, MS Project, Livelink, Minitab and Photoshop.

Initiator, Action oriented and Result focused Team player with zest to learn and improve.

EDUCATION

Masters in Medical Device Quality Management 2015

Grace College & Seminary, Winona Lake, Indiana, USA

MBA 2010

Leicester Business School, De Montfort University, UK

Specialization in Customer Relationship Management and Project Management

Graduate Certificate in International Business 2009

Leicester Business School, De Montfort University, UK

Bachelors of Commerce (Finance) 2004

Chhatrapati Shahuji Maharaj University, Kanpur, India

WORK EXPERIENCE

Zimmer Biomet, Warsaw, Indiana

Clinical Evaluation Writer June 2015- August 2015

Review CPS and make necessary changes.

Analyse clinical data from various sources.

DHF review and remediation.

Maintain CPS tracker and ensure reporting requirements are met.

Update documents on Livelink.

Approve CPS and maintain log.

CRY America (NGO)

Action Center Leader May 2013- December 2014

Organize and lead fund raising events for child rights organisation.

Recruit volunteers for events.

Represent CRY America at relevant community and other networking events to build brand visibility, secure sponsors and acquire new volunteers

Actively participate in corporate meetings and yearly conferences and represent CT chapter.

Enable accounting/banking.

Support the existing volunteer chapters through event planning, organizing and sponsorships.

Manage the document library and national volunteer data base for volunteers.

Inspire Management Consultancy April 2011-November 2012

PR and Marketing Manager

Analysed performance of all marketing programs to identify the best opportunities for optimization. Collaborated with marketing and communications teams on standardization, design and production of marketing materials. Created sales strategies to promote advertising offerings and motivate larger deals.

Developed PR strategy increasing client base and contacts.

Arrange networking events and analyse the outcome.

Developed the business website and maintain social networking advertisement.

De Montfort University June 2010- September 2010

Marketing Consultant (internship)

Marketing Consultant for University eMarketing Project ‘Conversion Mail’ for International Marketing.

Task involved develop and design advertisement drafts email it to universities and international students and establish interaction with them.

Selection of content and design of University International student webpage.

Arrange information of students assist them for course selection and application documentation.

Participated and interactively developed marketing video of De Montfort University.

Sunrise Hospital, Siliguri, India February2005-August 2008

Quality/Risk Analyst

Improve patient care and outcomes

Reduce the risk of adverse outcomes from patient care activities

Monitor compliance with regulatory and accreditation requirements and standards

Reduce and/or mitigate the risk of professional legal liability

Participate in risk management techniques such as Failure Modes and Effect Analysis (FMEA) Implement required changes in existing procedures.

REFERNCES: Available upon Request

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