Gaurang Kankotiya
Principal Engineer, Supplier Quality @Cardinal Health
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WORK HISTORY
Principal Engineer, Supplier Quality @Cardinal Health
Managing Supplier activities including but not limited to selecting, qualifying and onboarding new suppliers. • Responsible for managing Supplier Change Request (SCR), SCAR/CAPA, and Post-Market activities such as complaints, product hold, recalls and/or DPFA.• Managing Private Brands (PB) and Contract Manufacturing (CM)- sourced finished goods suppliers.• Completed a qualification project ahead of its\' timeline. This achievement resulted in recovering potential ~$3MM backorder ahead of schedule. • Working proactively to develop a new supplier to meet ISO13485 compliance as a finished goods (FG) medical device manufacturer, for a project impacting $4MM in supplier spend.• Helped a contract manufacturer develop and improve their QMS procedures. Coach them in technical writing and updating the change management procedure. This resulted in an excellent investigation of SCAR assigned to them and improved their QMS.• Aligning with the Supplier quality agreement, streamlined the change(s) proposed by the suppliers that do(es) not require SCR(s) to save time and effort of a cross-functional team.
EDUCATION
Gujarat Technological University, Ahmedabad
Bachelor of Engineering - BE, Mechanical Engineering
P.P. Savani Vidhyabhavan
High School, Department of Science
University of the Cumberlands
Master of Business Administration - MBA, Business and Personal/Financial Services Marketing Operations
Texas A&M University-Kingsville
Master of Science (M.S.), Industrial Engineering
ABOUT GAURANG KANKOTIYA
Demonstrated knowledge from working experiences as a Quality Engineer/Inspection/Assurance, Industrial Engineer, Manufacturing Engineer and Mechanical Engineer.A good team leader and Engineering Project Management Professional (PMP) Certificate holder.• Experienced in 21CFR 820.100 (CAPA), 21CFR 820.198 (Complaint files), 21CFR 820.90 (NC\'s), ISO 13485:2016, ISO 14971.• Led EU MDR 2017/745 project, transition from MDD to EU MDR. Led the transition to new compliance regulations EU-MDR 2017/745.• Result-driven Quality & Compliance Professional with a strong interest and understanding of Best Quality practices and regulatory standards in Medical Device industry such as ISO 13485, 14971, FDA 803, 806 and 820 QSR. Working knowledge of transferring design specifications into manufacturing specifications.• Worked closely with R&D, Quality and Regulatory functional groups.• Experience in development of potential hazards associated with new design inputs, user needs, design outputs and regulations.• Experience with Complaint Trending and Complaint investigations of various FDA reportable complaints.• Diversified skills include project management, Microsoft Office, CAPA, SCAR, IQ/OQ/PQ qualification, SOP writing, URS writing.• Experienced medical device manufacturing requirements (FDA-GMP, ISO 9001).• Extensive experience in FDA 21 CFR Part 11, CFR 211/210 validation, performing Gap analysis, Remediation Plan, SOPs, Validation Protocols, Technical Writing, Quality Assurance, Automated Test Tools and Test cases and Corrective and Preventive Actions (CAPA).• Skilled in Minitab, Root Cause Analysis, Problem Solving, Quality Assurance/ Regulatory Guidance, Microsoft Excel, Customer Service, and Engineering.• Seeking significant interaction with clinicians, customers, and internal teams to support technical and commercial efforts to develop and market products that make a difference in production and manufacturing environment.• Extensive experience participating in and supporting regulatory audits (FDA and MDSAP).• Proficient in HHEs, Field Actions, Risk Management Process, Design Reviews & Changes, Complaint/CAPA/SCAR investigations, Nonconformance reports, Gauge Rejection reports, Production & Process Controls, CGMP, Verification & Validations, Supplier Assessments, statistical analysis, drafting FDA responses.• Experienced in Class I, II & devices, supplier quality, SCAR\'s and supplier management.• Educated in Six Sigma methodology and trained employees in Lean Six Sigma, Design for Six Sigma (DFSS) & CAPA.
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