7711 N.W. 41st.

Street
Hollywood, FL 33024
(954) 432-5740
(954) 673-9946
vbajnath1@aol.com
Dec 2nd. 2009

Hiring Manager:

Dear Hiring Manager,

I am writing in response to your advertisement for one of the position QA Manager.

I am an accomplished, results-driven, experienced Manager providing solutions for domestic
organizations. I possess expertise in Quality Systems, Regulatory Affairs, Customer Service and
Manufacturing.

I have guided and led highly skilled, Quality and Technical support teams, conducted effective
Quality audits as well as working with ISO and FDA Auditors and have dealt directly with the
EPA and DOT

I welcome the opportunity to meet with you to discuss your needs and how I might use my
skills to add value to your organization. I know I can be an excellent asset to your operation.

Thank you for your consideration.

Sincerely,

Vikram Bajnath

Enclosure
 V I K R A M B A J N A T H

7711 N.W. 41st. Street H (954) 432-5740 ▪ C (954) 673-9946

Hollywood, Florida 33024 vbajnath1@aol.com

M A N A G E R , Q U A L I T Y R E G U L A T O R Y A F F A I R S M A N U F A C T U R I N G

An accomplished, results-driven executive manager, strong leader and mentor, providing

solutions for high-profile employers. Leverages domestic experience in Quality Systems,
compliance to the Quality policy, Customer and Technical Support, Internal Auditing, FDA’s
MDR reporting, trend analysis feedback of customer complaints for Medical devices, worked
with Engineering and other management to help prepare and review 510(K) filings. Effective
product performance analyst, solutions finder, and communicator. Served as a solid
contributor to the lasting success of an enterprise.

E X P E R I E N C E

HOME DIAGNOSTICS INC. Ft. Lauderdale, Florida

Senior Manager, Quality / Technical Support.
Apr. 1995- Nov 2009

Quality Systems functions - April 1995 to Nov. 2009-

 Functioned as a Quality Management Systems Internal Auditor (Lead Auditor).
 Established SOP’s for effective operation of 3 department’s operations.
 Conducted numerous GMP audits and Quality Reviews.
 Enforced policies, procedures and Quality standards to ensure continuous compliance.
 Prepared all audit plans for internal and external sources.
 Implemented annual audit plan for vendors, suppliers.
 Spearheaded the team that brought the company ISO 13485 for Medical devices approval in
2001( TUV Rhineland).
 Interacted heavy with distributors (Walgreens, CVS, McKesson etc.), Hospitals, Nursing facilities,
Managed care facilities, regarding product quality and performance of the BGM’s.
 ASQ and CEEM( ANSI-RAB) Quality Auditing certified.

Regulatory Affairs- Continuous

 Interacted with FDA and ISO auditors in the frequent audits and aided the RA department
with any 483 responses.
 Directly responsible for all of the FDA’s MDR submissions.

Complaint handling and Trending-1998-2009

 Technical support for all field complaints from end users of the Medical devices( Blood
Glucose Monitors)including device returns investigations and trend analysis.
 Managed a department of over 40 Techs including 10 Lead Techs and a department
budget of over $2 million.

A D D I T I O N A L E X P E R I E N C E

Gold Coast Chemicals Inc. Hollywood, Fl

Vice-President, Chemist 1990-1994
E D U C A T I O N
Professional Placement Network Program- Workforce1- Hollywood, Fl
Centennial College, Toronto, Canada
Major: BS Industrial Microbiology
University of the West Indies- Major : BS Chemistry

R E F E R E N C E S - U P O N R E Q U E S T