Kumar Arivanantham

Experience

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  FCA Fiat Chrysler Automobiles

  Aug 2013 - Jul 2016

  Supplier Quality Engineer

  Oversaw the SPC program and managed process and assembly control plans for precision and quality adherence. Conducted final inspections, meticulously measuring bogie frames against drawing datums, scanning for CAD model alignment, and marking machining references.Proactively addressed non-conforming dimensions, collaborating with fixture suppliers for corrective actions using dimensional measurements. Presented comprehensive quality metrics and recommendations to the team.Contributed significantly to developing and reviewing PFMEAs, control plans, inspection plans, and test plans, ensuring robust controls in production. Expertly estimated system reliability using Wei bull analysis.Conducted quality inspections, process audits, and played a key role in risk management, utilizing Fishbone diagrams and CAPA tools. Participated in customer audits, resolving quality issues to enhance customer satisfaction.Meticulously prepared documentation for performance, quality verification, qualification studies, and ISO compliance. Proficiently managed Risk Management assessments, PFMEAs, ISO Technical Reports, and Product Lifecycle documents. Developed Design of Experiments (DOE), Statistical Process Controls (SPC), and PFMEA.Efficiently handled Out-of-Specification (OOS) investigations, initiating CAPAs and change controls in compliance with regulations. Conducted attribute and variable test method validations, and reviewed PFMEAs and Master Validation Plans.Demonstrated expertise in quality tools like SPC, DOE, Gauge R&R, FMEA, CAPA, and process validation for ICP sensors. Supported internal/external audits, contributed to value stream mapping, and led CAPA-related investigations. Show less

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  Bonita Pharmaceuticals (VAWD Accredited)

  Jul 2018 - Aug 2019

  Quality Engineer

  Demonstrated expertise in statistical analysis using SPC and proficiency in essential quality engineering tools such as DMAIC, 5 Whys, process capabilities, and GD&T.Utilized supplier evaluation techniques, leveraging NCMR and NCR reports, and successfully implemented CAPA strategies to enhance product quality.Extensive experience in root cause analysis (RCA), requirement traceability matrix (RTM) design control, change of order processes, shelf life assessment, real-time and accelerated aging time (AAT) studies, as well as validation and post-market surveillance (PMS) activities, including 501K submissions.Developed comprehensive audit and inspection plans, ensuring the effectiveness of CAPA investigations while adhering to FDA and ISO standards, and regularly updating DHR documentation and SOPs.Proficiently authored protocols, reviewed/approved test methodologies for medical device compliance with regulations such as 21 CFR 820 and 803, actively contributing to product development.Led as a key contributor to quarterly releases, resulting in a remarkable 60% reduction in customer defects over four quarters through diligent RQA and PQA efforts.Played an integral role in the development of new products, including external drainage systems and Micro-shunt, overseeing test validation, changes, and DHF & NPD activities. Collaborated on Product Design Reviews and utilized PLM tools such as ERP and SAP.Executed Design Transfer activities by developing comprehensive line transfer protocols, ensuring seamless transitions between product development stages.Took the lead in design assurance and transfer activities related to Sustain Product Development (SPD). Show less

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  Siemens Healthineers

  Jul 2019 - now

  Commercial Product Engineer (R&D)