Mahesh R

About Mahesh R

Engineering professional in the Medical Device Industry responsible for providing…

Experience

1. Senior Quality Engineer

   Abbott

   Jul 2021 — Present

   Developed IQ/OQ/PQ protocols, conducted testing and wrote reports for products and manufacturing equipment for process validation. • Used statistical tools (Minitab) to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). • Experienced in creating/ updating pFMEA, UFMEA and other risk management documents according to the new complaint trends and risk classifications, connecting complaints back to the hazard modes. • Supported design control and risk management processes, including developing quality & risk management plans & reports; conducting hazard analysis, DFMEA, PFMEA; and authoring verification and validation protocols and reports. • Coordinated efforts to design, develop and validate manufacturing processes using tools such as Design of Experiments (DOE), Measurement System Analysis (MSA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), and capability analysis. • Provided timely resolution of product, process and equipment problems in the form of creative short and long-term solutions. • Defined approaches to test method operation, implementation and providing training of test methodology. • Conducted investigation, bounding, documentation, review, and approval of non-conformances, CAPAs and customer complaints. Escalated quality issues as needed. • Generated process flow diagrams through Visio for the manufacturing procedures, determine the individual sampling and testing requirements for each individual manufacturing process by using product specifications and manufacturing specifications as per the SOPs. • Created Process Maps, PFMEAs, Validation (IQ/OQ/PQ), TMV protocols and reports for remediation projects. • Developed IQ/OQ/PQ protocols, conducted testing and wrote reports as part of process validation activities