email@example.com 424-***-**** 9427 Haskell Ave North Hills, CA 91343
**/**** – 06/2013 Vellore Institute of Technology, Vellore, Tamil Nadu, India
Masters of Technology in Biomedical Engineering (CGPA 7.99/10)
06/2007 – 06/2011 Sam Higginbottom Institute of Agriculture in Biotechnology, Allahabad, Pradesh India
Bachelors of Technology in Technology and Sciences (CGPA 7.28/10)
09/2017 – Present Abbott, Sylmar, CA
Product Surveillance, Supervisor
Provide supervisory responsibility for team of 12 Product Surveillance Analyst.
File regulatory deliverables as required (FDA Inquires).
Maintain a working knowledge of regulations and standards related to post-market quality and complaint handling.
Manage weekly team meetings.
Run reports in business objects and analyze the data as required.
Implement root cause problem solving method to help improve procedures.
Cross-functional collaborator with risk management and engineering teams for Risk Management file updates.
Owner of the Corrective and Preventive Action (CAPA) and a support member for multiple CAPA owners.
Communicate with other Quality teams for continuous process improvement. Provided support during regulatory inspections, including FDA and third-party Audits.
06/2015 – 09/2017 Abbott, Sylmar, CA
Product Surveillance, Analyst I
Review all complaints and assess their reportability to FDA.
Review, interpret, and enter product analysis results into the database.
Review all complaints and assess the need for supplemental reports as new information is received.
Prepare and file initial and supplemental reports in a timely manner per FDA requirements.
Complies with (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Determine root cause analysis. Investigate and evaluate complaints made against St. Jude Medical devices to determine reportability to FDA.
Apply knowledge of cardiovascular physiology, cardiac rhythm management device functionality and specifications, and FDA medical device regulations to review, interpret, and enter product analysis results into the database.
Professionally communicate with field personnel: physicians, nurses, engineers, health care professionals.
Use understanding of current standard operating procedures to develop and implement corrections in the process to improve the current reporting work instructions and reduce errors within a complaint record.
Organize interdepartmental meetings to establish and maintain up to date detailed work instructions.
Collaborate with team to complete and submit several thousand Medical Device Reports monthly.
Knowledge of FDA Section 515,522 and 21 CFR Part 803,806,820,821
09/2014 – 05/2015 Jobtracks, Marina Del Rey, CA
Responsibility includes website building and maintenance, email marketing, SEO, maintaining company social media account, clerical work, troubleshooting technical issues related to recruiting software and job board network.
08/2013 – 01/2014 First Medical, New Delhi, India
Biomedical Sales Executive
Job responsibilities were sale and application of medical devices such as radio frequency ablation machine for varicose vein, laparoscopic instruments and super oxidized water generation system for surface disinfection.
07/2012 – 05/2013 Fiber reinforced Polymer Hydroxyapatite composite for orthopedic load bearing application from CSIR NML Jamshedpur Microbiology, India
Duration: 9 months (Done during 4th semester, M Tech)
Research The project was about using natural fiber to increase the compressive strength of a polymer matrix embedded with hydroxyapatite crystals as particle reinforcement (similar to the human bone) to a level which is identical to human bone.
The purpose of this project was to develop bone graft material with excellent mechanical strength and regenerative property.
11/2010 – 05/2011 In vitro propagation studies on the medicinal plant aloe Vera in Brabant from plant tissue culture department brightbio Delhi, India
Duration: 3 months (Done during 8th semester, B Tech) Techniques
The project was about vegetative propagation of aloe Vera plant using its shoot and optimizing the procedure protocol to obtain maximum shoot proliferation and explant survivability.
Tools: MATLAB, Origin, X'Pert highscore, Minitab, WordPress,Google Analytics, Webmaster Tools
Applications: MS Excel, MS Word, MS PowerPoint
Platform: Windows 7/8, Mac OS
Lab Skills: PCR,DNA extraction, Agarose gel electrophoresis