Find Unlimited Emails.For Free.
Discover prospects, find their business emails, and build your pipeline with Unifers.
Start for FreeSandhya Kota
Sr Quality Assurance Engineer @Tosoh Bioscience, Inc.
Signup · Get unlimited contacts
WORK HISTORY
Sr Quality Assurance Engineer @Tosoh Bioscience, Inc.
Grove City, OH, US
Serve as owner of NC & CAPA and perform investigation activities within the Quality Management System, ensuring root cause analysis and prevention of recurring issues. Lead root cause analysis training and coached Supply Chain, Purchasing, and Customer Service teams in problem-solving methods including 5-Why, Fishbone (cause-and-effect), and human error reduction techniques Managed CAPA investigations and Supplier Corrective Action Requests (SCAR) across nonconformances, supplier issues, and complaint-related events, ensuring timely closure and compliance with FDA and ISO 13485 requirements. Coordinated and Supported TUV audits for four (4) years by performing audit preparation and follow- up activities, performing gap analysis, and cross functional improvement activities to ensure audit readiness. Verify effectiveness of corrective and preventive actions through data analysis and objective evidence, reducing recurrence of quality issues. Facilitate cross-functional investigations with R&D, Operations, and Suppliers to resolve complex quality problems and improve product reliability. Develop and track QMS metrics (CAPA, NC, complaints), driving continuous improvement and achieving up to 79% reduction in defects and 20% reduction in complaints. Led nonconforming material review board (MRB), product disposition, and recall-related activities to ensure compliance and risk mitigation. Perform internal and supplier audits, ensuring adherence to FDA regulations and ISO 13485 standards. Lead validation and qualification activities for suppliers, components, and processes, ensuring alignment with product and regulatory requirements. Improve inspection criteria and supplier quality performance through collaboration with cross-functional teams and data driven decision making. Drive SCAR activities with suppliers, including root cause analysis, corrective action implementation, and effectiveness verification to improve supplier performance.
EDUCATION
Illinois Institute of Technology
Master's degree, Chemical Engineering
R.V.R. & J.C. College of Engineering
Bachelor’s Degree, Chemical Engineering
University of the Cumberlands Graduate and Online
Master of Business Administration - MBA
Anna University Chennai
Master's degree, Petroleum and Polymer Engineering
ABOUT SANDHYA KOTA
No sponsorship required. Quality Engineering leader in the medical device industry with 8+ years of experience driving product quality, supplier performance, and regulatory compliance (ISO 13485, FDA 21 CFR 820, EU MDR). I specialize in leading cross-functional quality and continuous improvement initiatives, identifying systemic gaps, and implementing sustainable solutions that improve product reliability, reduce risk, and strengthen compliance across the product lifecycle. Key contributions include- Reduced product damage by 79% through root cause analysis and preventive supplier quality strategies - Eliminated recurring temperature-related defects across 6 consecutive months - Led supplier quality initiatives including qualification, audits, CAPA, and nonconformance investigations - Drove Kaizen and continuous improvement initiatives to enhance inspection processes, reduce defects, and improve operational efficiency - Partnered with R&D, procurement, and manufacturing to ensure end-to-end quality alignment I actively lead and influence quality culture and capability building- Deliver training programs on Gemba Walks, Good Documentation Practices (GDP), inspection readiness, and investigation methodologies - Mentor teams on root cause analysis, problem-solving, and compliance mindset - Promote a Kaizen-driven culture of continuous improvement and proactive quality ownership I am an ASQ Certified Lean Six Sigma Green Belt, leveraging data-driven methodologies to- Reduce cost of poor quality (COPQ)- Improve process capability and efficiency - Drive risk-based decision-making and sustainable improvements Currently expanding my impact in supplier quality leadership, validation, and strategic quality systems, with hands-on involvement in- Equipment and room validation initiatives - Supplier performance management and audit leadership - Inspection and quality system improvements I am seeking Lead Quality Engineer / Principal Quality Engineer / Supplier Quality Lead roles where I can- Lead and scale continuous improvement initiatives - Drive systemic quality transformation - Mentor teams and elevate organizational quality maturity - Influence supplier quality strategy at a global level
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.