Rohan Anand Kalvala
Senior Quality Engineer @Luminex
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WORK HISTORY
Senior Quality Engineer @Luminex
Austin, TX, US
Trained personnel on Risk Management methodologies, fostering a proactive approach to hazard identification and mitigation.• Overhauled documentation review workflows and cutting documentation errors by 50% within the Service/Repair Facility (Depot) for refurbished instruments.• Established Critical manufacturing instructions, datasheets, Device History Records (DHRs) and rework loops, to enhance production efficiency by 25%.• Defined test fixture requirements and implemented preventive, unscheduled maintenance protocols for screening devices leading to standardization of Inspection process• Led Validation and Verification initiatives for a new instrument manufacturing line by orchestrating Equipment Qualifications (IQ/OQ) and driving Process Verification to ensure operational excellence and compliance.• Addressed multiple Corrective and Preventive Actions (CAPAs) to bolster traceability and defect detection within Field Service, Manufacturing, and Research Engineering.• Mentored professionals in the application of CAPA problem-solving tools, strengthening issue resolution processes based off Lean Manufacturing principles.• Coordinated with Incoming Quality Control (IQC) and R&D engineers to establish Critical Quality Attributes (CQAs) and Critical Material Attributes (CMAs) for product integrity.
EDUCATION
University of Houston
Master’s Degree, Industrial Engineering
Muffakham Jah College Of Engineering And Technology
Engineer’s Degree, Mechanical Engineering,Specialization in Production Engineering
ABOUT ROHAN ANAND KALVALA
Problem Solver and Performance driven. Hands-on CAPA experience for field Re-Calls.Proficient in relevant National / International standards for Medical Devices.Guidance to quality and compliance per FDA 21 CFR part 820 & ISO 13485.IQ/OQ/PQ, process validations, adept with Clean rooms and ISO Class 8 environments. Successful in Executing Cleaning validations and adoptions. Achieved Takt time reduction as well as Cost savings with implementation of Lean Six sigma principles within the Value stream. Submitted Manufacturing Summaries for critical DHF Scopes for EU MDR. Risk Evaluation and Remediation(PFMEA,DFMEA,UFMEA) for critical on market productsEnforced multiple Poke yoke within the Manufacturing Processes.Industrial Tools: Lean manufacturing, A3,5S, Kaizen, Value Stream Mapping, Time & Motion studies, Line Balancing, DMAIC, Lean Six Sigma, Statistical Process Control(SPC), FMEA, Cost-benefit analysis, Root Cause analysis, SIPOC, Hypothesis Testing, DOE, 5 Whys, Gemba Walks.Software tools : Enovia, CMS, Info-PV(Makromed), Teamcenter, ETQ, AS400 & Infor XA, JD edwards, SolidWorks,Agile,Oracle,Smartsolve
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