Quality Engineer
Resume:
Malhar Shah
*********@*****.***
www.linkedin.com/in/iammalhar
OBJECTIVE
To perform daily management and maintenance of the Engineering division through my dedication, cross-functional communication, knowledge of FDA Quality System Regulations (QSR) 21 CFR 820 & ISO regulations, troubleshooting and testing skills on different medical devices to execute the analysis and determine the root cause & corrective actions on the product, generate test results provided with my technical support on the product development, verification and validation of products according to company's processes and to maintain proper documentation for technical procedures in the pursuit of patient care and the advancement of human health. SUMMARY
I offer exemplary academic achievement augmented by four years of experience and knowledge in the medical device industry – as a Quality Affairs Specialist at Medtronic and previously a Field Service Engineer at Philips Pvt. Ltd. My knowledge of FDA QSR 21 CFR 820 and ISO 13485 and troubleshooting & testing skills on different medical devices along with strong interaction with other teams can be put to valuable use in your facility. EDUCATION
University of Massachusetts, Lowell, MA, May 2017
Master of Science, Biomedical Engineering & Biotechnology Cumulative GPA: 3.92
Ganpat University, Kherva, Gujarat, India, June 2014 Bachelor’s in Technology, Biomedical & Instrumentation Engineering Cumulative GPA: 3.7
RELEVANT WORK EXPERIENCE
MDR/PMV Consumer Affair Specialist – (Populus Group) Medtronic, Boulder, CO July 2017 – Present
• Evaluate, analyze, and provide trending data on all the incoming complaints information; maintain records in the electronic database and detect trends in the complaints using FDA and Medtronic Internal codes.
• Determine complaint reportability to both government and Medtronic internal agencies; ensuring record documentation is retained in a constant state of audit readiness per internal policies.
• Communicate and liaise with Manufacturing and Engineering, Technical Service, Failure Investigation, Research and Development, and Quality Assurance within Medtronic and with customers for complete and comprehensive complaint processing.
• Providing basic technical expertise and assistance in handling complaints to comply with current FDA and international reporting regulations.
• Effectively helping team with different projects to maintain company's goal.
• Review and interpret risk management documentation as it applies to the complaint event.
• Determine the failure analysis for the relevant complaint mode to ensure compliant reporting and analyze reports and defective products to determine trends, recommend corrective actions and Foreign Experience Reporting.
• Effectively communicate with the customer and Field Service Engineer to ensure timely responses, correction and closure of the incoming complaints.
• Supporting other teams with my technical knowledge and helping them in the translation of the non-English text for timely complaint closure.
Field Service Engineer – Philips Pvt. Ltd. India (Care Mediquip), Mumbai, India Dec. 2014 – July 2015
• Performed installation, troubleshooting, repairs and planned maintenance of medical devices – ultrasound machines, patient monitoring, defibrillators, ECGs & fetal monitors, and ventilators.
• Experience in installing software on the different Philips medical devices such as Ultrasound, Patient Monitor and many more.
• Developed extensive knowledge of all the entire series of an ultrasound machine (HD series) along with its hardware and working flow process from the CPU to E-box.
• Gained the field knowledge to understand the change and development of the medical device for the effective and lasting operation necessary for Safe patient care.
• Assisted the sales team in providing overviews of the ECG and patient monitor products
• Attended two technical seminars for hands-on training on patient monitoring and defibrillator devices. Intern – CIMS Hospital, Ahmedabad, India June – July 2013
• Assisted the biomedical engineer in the servicing of different medical instruments used in various department of the hospital.
• Operated different tools such as power supply, multimeter, oscilloscope that are useful in servicing of different medical devices.
PROFESSIONAL SKILLS
Troubleshooting, problem-solving; failure analysis; Root-cause analysis; cross-functional support; FDA 21 CFR 820; Quality System Regulation (QSR); ISO 13485; CAPA knowledge, working knowledge of SAP, MATLAB, LabVIEW, MS Office, PERL, FilterPro, MultiSim, Philips Central Nursing System software, Philips Patient Monitor Software, Data Analysis, Supervision.
ACADEMIC PROJECTS
Biomechanical Chair January 2016
• Worked on a research project aimed to provide maximum support to the spinal cord to soothe the pain caused during prolonged sitting.
• Identify the maximum area of contact & suffering caused - and with the proper back support, reduces the deformation of the lumbar discs and its contribution to the disc pressure.
• Worked in the lab to design a back support of the chair by determining the changes in voltage on different subjects before and after providing back support; analyzed the data for finding a correlation. Wireless EMG Analysis June 2014
• Collaborated with a small team to develop a circuit to capture EMG signals from the body and use it as a diagnostics tool for identifying diseases.
• Constructed a circuit to capture the EMG signals and used general measurement instruments such as an oscilloscope to record and analyze the signals.
• Recorded the EMG signal from the patient and compared it with the regular EMG signal for detecting an anomaly.
CERTIFICATION
• Successfully completed the CITI Program course titled ‘Human Research Biomedical Investigators 1’. ACHIEVEMENTS
• Awarded first runner-up in a Poster presentation “Techniques of 3D Scaffold Synthesis” Conference on Indian Medical Devices & Plastics Disposables Industry; January 2013.
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