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Quality Engineer

Buffalo, NY
October 14, 2018

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Prachi Verma, CQE

*** **** ******, *********, *************,02048, United States• phone #937-***-****


University at Buffalo, State University of New York, Buffalo, United States MS Biomedical Engineering, GPA:3.90/4 February 2018 University of Nottingham, Nottingham, United Kingdom MSc Bioengineering, GPA: 6.78/10 December 2009

Amity University, Uttar Pradesh, Noida, India

Bachelor of Technology in Biotechnology, GPA:7.41/10 June 2008 EXPERIENCE

DePuy Synthes, Johnson & Johnson, Raynham, Manufacturer of orthopedic devices (Class I, II & III) May 2018 - Present Quality Engineer II

Investigation of customer complaints for product quality issues and concerns

Initiating product failure investigations and take the lead in failure investigation teams

Filing MDRs and MDVs

Developing and utilizing statistical tools to analyse complaints for trends, root cause analysis, and initiate corrective action

Interfacing with key business partners including R&D, Operations, Medical, Marketing and Post Market Safety Surveillance to ensure a thorough investigation is completed

Fresenius Kabi, Buffalo, Manufacturer of injectible drugs June 2017- May 2018 Quality Engineer

Working in partnership with manufacturing operations, research and development, quality control and assurance, engineering, maintenance to solve problems and provide support on compliance issues and corporate quality policy requirements relating to critical systems

Responsible for evaluating for compliance and approval of Preventative Maintenance and Qualification activities for all critical systems

Performing Risk management using FMEA

Reviewing validation protocols including Site Acceptance testing and IQ/OQ/PQ Soma-Medical, New Delhi, India, Manufacturer of orthopedic devices (Class 1 & II) Feb 2013 - Aug 2018 Quality Engineer

Undertaking non-conformance analysis, investigated deviations & performing root cause analysis by using Quality tools such as Fishbone diagram, Pareto chart and Histogram

Releasing finished product with QA approval and performed traceability functions as per QSR/FDA/ISO requirements for

~2500 devices per week

Reducing product failures by 15% throughout plant by implementing countermeasures through root cause analysis to resolve quality issues

Conducting cGMP audits and managing quality control documentation including CAPA & CRF Proline Botanicals, Stamford, United Kingdom, Manufacturer of pharmaceutical products Dec 2010 - Jun 2012 Quality Control Analyst

Performing Qualitative & Quantitative analysis of drugs using HPTLC and HPLC

Conducting routine and non-routine analysis of in-process materials, raw materials, finished goods, and stability samples

Managing internal cGMP audits and collating findings into appropriate metrics

Preparing technical documentation including deviation reports, testing protocols and trend analysis CERTIFICATIONS

ASQ Certified Quality Engineer (Certification Number -98572), ISO 9001:2015 Internal Auditing Course (ASQ)

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