Madhumita Srikanth
Senior Quality Engineer @ZAP Surgical Systems, Inc.
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WORK HISTORY
Senior Quality Engineer @ZAP Surgical Systems, Inc.
Managed the complaint handling system, ensuring timely and thorough investigation of customer complaints.• Conducted complaint investigations to identify root causes and implemented corrective actions to enhance product quality and customer satisfaction.• Implemented process improvements in complaint handling to streamline workflows and improve compliance with regulatory requirements.• Served as the CAPA (Corrective and Preventive Action) Manager, overseeing CAPA investigations and ensuring alignment with quality and regulatory standards.• Reviewed and approved Nonconforming Material Reports (NMR) and Returned Material Authorization (RMA) root cause investigations and dispositions to ensure compliance with quality standards and regulatory requirements.
EDUCATION
Stanford University
Product Management: Transforming Opportunities into Great Products
Amrita Vishwa Vidyapeetham, Coimbatore
Bachelor of Technology, Electronics and Instrumentation
Stanford University
Bachelor's degree, Mastering Product Management: Building your Strategy
The University of Texas at Arlington
Master's degree, Bioengineering and Biomedical Engineering
Bala Vidya Mandir
High School
ABOUT MADHUMITA SRIKANTH
Masters in Biomedical engineering with 5 years of experience. Experience with Medical Device Regulations (ISO 13485, FDA 21 CFR 820, ISO 14971, IEC 62304). Problem Solver and Customer-focused product professional. As a product manager with a background in bioengineering and healthcare quality engineering, I am passionate about bringing innovative medical devices to market. With five years of experience in project and product management, I have a proven track record of leading cross-functional teams to deliver high-quality products that meet regulatory requirements.I am well-versed in medical device regulations such as ISO 13485 and FDA 21 CFR 820, and have experience in Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, and Statistical Process Controls (SPC). I have managed all aspects of new product development, from concept design to prototyping and engineering change orders (ECOs), as well as risk analysis.My recent certifications in product management and human factor excellence for medical device design from Stanford University and Marcus Evans Group have further equipped me with the skills to transform opportunities into great products.Currently, I am a Quality Engineer-Product Management Liaison at Iridex Corporation, where I have successfully managed project teams to deliver complex medical devices on time and within budget. I have also been instrumental in collecting customer feedback and working with the engineering team to improve current products and add new features.In addition to my experience in product management, I have a strong technical background in biomedical engineering. As a biomedical engineer at Prime Healthcare, I evaluated and implemented solutions for complex biomedical equipment issues in various medical settings. As an engineering intern at Omnicell, I oversaw the quality control process and assisted in the transfer of design to contract manufacturing.My technical skills include proficiency in MATLAB, SolidWorks, MS Office, AutoCAD, Jira, Minitab, LabView, Eagle, C, SQL, Figma, and Tableau. I also have strong communication skills and experience in content writing, presentation, and digital and social media marketing.I am interested in Quality Engineer based roles and product manager roles (Technical PM, APM, PM based roles) in the Healthcare industry and would welcome the opportunity to discuss how I can contribute to your organization\'s success.
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