Samir Rajput Email & Phone Number

California, United States

Thousand Oak, Ca

➤ Taking on an additional role as Instructor of the Devices, which entails disassembling and assembling the device to train others, as well as providing instruction in the proper execution of root cause analysis process and tools.➤ Leading failure analysis of mechanical and electromechanical products to identify root cause using tools such as tolerance analysis, fishbone diagrams, “5 Whys”, and risk assessments such as FMEA's and Fault Tree Analysis.➤ Overseeing and performing technical trend and consolidated investigations, statistical assessment of data to identify trends, and evaluation of returned product, product reserve sample inspections, batch records, and complaint histories.➤ Ensuring the validity of statistical assessments, and developing relational data analytics in support of investigations, while advising management on needed trend and failure investigation process improvements.➤ Leveraging knowledge of customer use of products and manufacturing processes to pinpoint usability and product design issues, supporting functional management initiatives and objectives.➤ Leading root cause analysis to identify the failure mode for mechanical and electromechanical medical devices and associated product components such as packaging returned due to product complaint.➤ Successfully owning CAPAs to support identification of design solutions based on root cause, and participating in multi-functional ideation of design solutions, including providing input to Engineering for product improvements.➤ Effectively partnering with Device Engineering to develop failure analysis processes and tools for current and future device platforms.

QA Engineer, Level III – Johnson & Johnson, Irvine, CA – 2018Quality Compliance Specialist – Masimo (Marque Staffing), Irvine, CA – 2014 to 2015Quality Assurance Compliant Specialist II – Dexcom (Insight Global), San Diego, CA – 2014Sr. QA Engineering Technician, Supplier Receiving Inspection (RI) – Boston Scientific, San Clemente, CA – 2013Quality Control Technician – Micro Vention (via Staffing Agency), Irvine, CA – 2009Quality Assurance Associate Analyst – Allergan (Adecco Staffing), Irvine, CA – 2008

(Formerly Known As Carefusion/Bd) – Yorba Linda, Ca

➤ Effectively represented the customer-facing Department responsible for managing the customer experience through product feedback, while owning customer complaint lifecycle management and monitoring product quality.➤ Worked closely with Failure Analysis labs to drive resolution to customer complaints, regulatory reporting, and to facilitate continuous improvement driven by complaint data, trending, and analysis.➤ Played a key role in ensuring post-market compliance to EU Medical Device Reporting and other evolving regulatory requirements, including generating reports for submission to the FDA with 100% accuracy.➤ Closely monitored trends related to complaints and escalated issues to management, while evaluating documentation for completeness and consistency, and assigning additional actions as necessary to close complaints.➤ Reviewed technical service calls to ensure they were properly taken, and determined appropriate classification of the complaint, submitting in accordance with company procedures.➤ Contributed to contract negotiations, including software licensing and hosting agreement, and effectively helped manage external vendor relationships, in additional to facilitating sample return and investigations by suppliers.➤ Participated and supported internal and external audits and inspections, and helped ensure teams were addressing critical customer needs and maintaining best-in-class standards for grade of service along with time to resolution.➤ Proactively developed relationships with key internal and external customers to identify, facilitate, strategize, and prioritize the necessary activities in order to meet the business objectives.

Irvine, Ca

➤ Successfully led a group to evaluate and complete a detailed Complaint investigation, applying best practices and established standards, as well as developed and performed quality/compliance audits based on regulatory requirements.➤ Helped coordinate all aspects of Quality and Compliance programs, including training and coaching new employees on related issues as appropriate, and contributed to facilitating change management throughout the Department.➤ Supported leadership with project prioritization and development of clinical technology strategy, as well as applied out-of-the-box thinking to solve complex problems to ensure deadlines were met.➤ Aided in internal audit of clean room from assembly line to final inspection, and expedited evaluation of MDRs, while also reviewing Device History Records and monitoring rejects and NCMRs.➤ Expertly performed complaint trending, generated metrics, and monitored trends to determine CAPA needs, as well as created reports for R&D Engineers and upper management.➤ Contributed to setting-up UDI for the EU and other countries, and provided training to QC Final Inspection team and internal team members on complaint handling processes, product knowledge, and root cause investigations.➤ Effectively supported R&D, CAPA team as a team member), Manufacturing, and Quality Engineering with projects to assess the severity of customer feedback and construct meaningful strategies for optimal root cause resolution.

Bachelor'S Degree, Business Economics

Activities and Societies: Active Member of American Society of Quality

Associate'S Degree, Chemistry