Consult Tech Inc

CONSULT-TECH

INC.

Vik Bajnath Hollywood, Florida 33024 C

H (954) 432-5740 ▪ C (954) 673-9946 [email protected]

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An accomplished, results-driven consultant, 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, will work with Engineering and other management to help prepare and review 510(K) filings and FDA and ISO audits and FDA 483 responses. Effective product performance analyst with 15 years Blood Glucose monitor device experience, solutions finder, and communicator. Will serve as a solid contributor to the lasting success of a Medical device enterprise. E

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Ft. Lauderdale, Florida Apr. 1995- Nov 2009

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Quality Systems functions 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 . Interacted heavy with Distributors, Hospitals, Nursing facilities, Managed care facilities, regarding product quality and performance of the Blood Glucose Monitor systems.

ASQ and CEEM( ANSI-RAB) Quality Auditing certified.

Regulatory Affairs 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 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.

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