Quality control/assurance for medical devices, regulatory affairs

MANJEET PUNEKAR

**** ********* *****, #*** 213-***-****

Los Angeles, CA 90007 **********@*****.***

EDUCATION:

Master Of Science, Biomedical Engineering May 2011

University Of Southern California, Los Angeles, CA

Bachelor Of Technology, Biotechnology May 2009

SRM University, Chennai, India

RELEVANT COURSEWORK:

Biomedical Measurement and Instrumentation Advanced Topics in Biomedical Systems

Introduction to Bio-MEMS and Nanotechnology Six-sigma quality resources in health care

Quality Systems and Standards Quality Management for Engineers

TECHNICAL SKILLS:

Languages/Tools and OS : C, MATLAB, Windows 9X/2000/XP/Vista, Macintosh

Other Relevant Skills : Proficient at handling biological devices/laboratory equipment

ACADEMIC PROJECTS:

Detection of ESBL Positive Strains in Clinical Samples Spring 2009

Detected antibiotic sensitivity pattern of samples taken from patients suffering from urinary tract infection. The percentage of resistant strains was determined and alternate antibiotics were suggested.

Piezoelectric Microcantilever Sensor Assay for Infectious Disease Diagnosis Fall 2009

Proposed a novel, multiplexed and cost-effective microfluidic system to detect various microorganisms and their toxins in bodily fluids. This was based on a piezoelectric microcantilever sensor assay system designed to elicit a unique response to each preselected organism. The model was determined to be feasible in terms of simultaneous detection of multiple disease-causing agents.

Popcorn Production as a Medical Device Simulation Spring 2010

Simulated the manufacturing of a medical device by producing popcorn using current Good Manufacturing Practices (cGMP). Having been familiarized with Quality System Regulations, prepared quality control documentation for the simulation.

Quality Audit Project Spring 2010

Performed a thorough mock audit of documents and procedures submitted by a medical device manufacturing company to ensure quality and compliance with standard regulations. Created a checklist, determined reasons for inadequacies and proposed possible solutions.

Simulation of Aortic Pressure Responses with/without Intra-Aortic Balloon Pump Fall 2010

Designed a MATLAB-based system to simulate aortic pressure responses in the human body using an intra-aortic balloon pump, with inflation and deflation occurring during the diastole stage of the heart cycle. The system was based on 3-parameter and 4-parameter Windkessel models.

Quality Manual for a Startup Company Spring 2011

Invented a mock startup company to launch a service and created a thorough quality policy and quality manual for the same. The quality manual, along with the required records and documents, was prepared in accordance with ISO 9000 regulations.

RELEVANT EXPERIENCE:

JASMN Research Foundation, Chennai, India Dec. 2008 - Mar 2009

Assisted lab technicians with preparing reagents and equipment for the processing and testing of blood samples, collected from patients suffering from various conditions.

Performed tests for the characterization of cells, cultures and the identification of various organisms.

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