SAMIP SHAH

• Leading Complaints Operations team: Leading and Managing daily metrics, Trend analysis of complaints, performing technical investigations for identifying trends, supporting root cause investigations and engineering escalations
• Driving data analysis of quality performance to identify high priority issues relating to safety, complaints, customer satisfaction and the complaint process
• Synthesized complex analytics-derived insights into easy-to-understand, actionable recommendations for business users.
• Collaborated with business-unit leaders to identify and prioritize problems.
• Identified, analyzed and interpreted trends or patterns in complex data sets to translate findings into actionable outcomes..
• Utilized data visualization tools to effectively communicate business insights.
• Collaborated with stakeholders to identify business needs and data sources.
• Used statistical methods to analyze data and generate useful business reports.
• Created dashboards to monitor and track key performance indicators.
• Created data models to support decision-making processes.
• Generated ad-hoc reports to evaluate specific business requirements.
• Identifying drivers of complaint volumes and emerging trends with understanding of relationship between customer satisfaction, business results, and complaint volume trends and Quantify business impact of dissatisfaction across lines of business
• Communication with business partners to facilitate discussions around complaint drivers and impacts along with development of standardized complaint analysis frameworks that can be leveraged across businesses and functions
• Preparing clear & informative presentations on tracking and trending for Management Review and monthly Complaint Board Review (CRB)
• Supporting trend data requests for Competent Authorities (FDA, BSI and other regulatory bodies)
• Leading Continuous improvement projects to improve the performance of Complaint Handling Unit
• Supporting and participating in FDA, Global and internal audits

Projects and Achievements:

• Successful completion of continuous improvement training and implementation of Weekly Complaints management dashboards (DMB); which helped leadership team to focus in right direction
• (Average lead time to close complaints has been dropped to 24 days in 2021 from 160 days in 2020)
• Successful completion of Defect kaizen event on failure code trending ; making the complaints trends data more meaningful and actionable for Engineering/R&D team
• Establishment and participation of monthly signal assessment to identify and escalate any adverse trend
• Establishment of ARO trending and quarterly reporting mechanism

• Evaluate, investigate, track and complete complaints through effective and established complaint handling process
• Ensure accurate documentation of evaluation and investigation results with the assigned complaint records
• Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings and in CAPA review board meetings
• Coordinate with the complaint investigators in providing any missing information for initial evaluation of complaints
• Collaborate with Engineering, Customer Support, Field personnel, Market Service Order reviewers and other appropriate groups for adequate root cause investigations of complaints
• Collaborate with Adverse Event Coordinators for reportable complaints as well as Product Safety Committees for Correction and Removal process
• Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data gets pushed to the appropriate departments for actions
• Support reviews and audits assigned
• Work with the Post Market Surveillance Manager for any other projects

Projects and Achievements:

• Completed the project on creating reports of customer facing issue- Complaints Symptom Report for improvised trending data and assist engineering to resolve most frequent customer facing issues for future releases
• Completed Kaizen project for Process Improvement of complaints, which included developing strategies for complaint trending & data analysis using lean tools
• Completed similar complaints project for trending on most frequent issue and help reducing complaint cycle time-Developed mechanism to identify similar complaint
• As of 2015 overall similar complaint rate was about 5% of the entire population which went up to 25% in year of 2016 after as a result of this project

• Perform the verification testing of a medical CT scanner
• On scanner testing of Image Reconstruction algorithms
• Participate in large project software integrations
• Develop automated tests for production software
• Document of Testing and improvement of test procedures
• Software deliveries for the CT scanner product beta and release
• Assist in software development of a medical CT scanner, develop test software to test production software
• Test Image Reconstruction & processing algorithms
• Experience in a team environment with a track record of meeting specified project deadlines

Projects and Achievements:

• We worked hard as a team to accomplish the remediation work and ongoing projects and as a result 4.1 project was released on time which was a major achievement for company as it made company to restart the production
• Our CIRS team was the first as a subsystem level who submitted all the test results and final report before the deadline and helped other cross functional teams to meet the project deadline.

• Undergone training and had rotations in the maintenance of various Patient monitoring devices and equipment like CT, MR, SPECT/PET
• Familiar with the Standard of Protocols of maintenance of biomedical equipment
• Obtained practical experience with methods and technologies within various departments of the hospital
• Validation, calibration, and troubleshooting of the instruments used in hospital with both software and electromechanical aspects such as Syringe infusion pumps, Bio-monitor, BP machines and Ventilators.