Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

SAIRAM PASUMARTHY

Austin,TX

Summary

Senior Quality Engineer with over 5 years of experience in enhancing production efficiency and validating manufacturing processes. Expertise in statistical analysis, root cause analysis, and technical documentation, leading to increased throughput and reduced non-conformances in medical device sector. Proven ability to manage Quality Management Systems and execute process validations, ensuring compliance in regulated environments. Proficient in SolidWorks, Minitab, and various Microsoft applications, with strong skills in team leadership and communication.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Senior Quality Engineer

Abbott
, TX
02.2021 - Current
  • Developed and implemented quality plans and Standard Operating Procedures (SOP) and Quality Management Systems (QMS) following ISO 13485 and 21 CFR Part 11/820 and other regulatory standards.
  • Planned, executed, and documented FAT/SAT commissioning activities and validation activities (IQ/TMV/OQ/PQ) and revalidations for automated manufacturing lines across multiple factories.
  • Provided mentorship and technical guidance to validation engineers and cross functional team members supporting validation executions, root cause and CAPA investigations and documentation practices.
  • Experienced in SMT fabrication process and validating Automated Vision Systems, UV Curing systems, Laser Cut processes, Adhesive Dispensers, Leak Detectors, Functional Testers, Reflow Oven, Auto RFID Machines and E-Beam.
  • Conducted DOE to identify variations in the manufacturing process to determine the optimal parameters to achieve process capability.
  • Drafted, reviewed, and approved Engineering Change Orders (ECO), Deviations, Bill of Materials (BOMs), SOPs, Preventive Maintenance Procedures (PMPs), Work Instructions (WIs), URS requirements, DHRs, Validation Plans, Protocols and Reports and decommissioning activities.
  • Collaborated with cross functional teams to develop Process Flow Diagrams (PFDs), Process Failure Mode Effect Analysis (pFMEA) to mitigate or eliminate risk and ensure compliance with ISO 14791.
  • Experienced in investigating and reviewing non-conformance material reports (NCMRs), Audit Findings and drive CAPA activities with development and documentation of problem statements, containment activities, root cause analysis and actions plans with effectiveness monitoring.
  • Analyzed and interpreted TMV data using statistical tools like Minitab to determine whether systems and processes have met validation criteria.
  • Streamlined the change control process for the TPM site to reduce gaps, improve approval processing time and standardize the validation and change control process.
  • Managed multiple mid-volume and high-volume lines retrofit validation activities across various factories to ramp up production from 100,000 to 5M+ units per month to achieve business goals.
  • Directed and mentored supplier validation engineers to create validation documents, manage executions and facilitate working sessions with cross functional teams.
  • Interfaced directly with site leadership and global teams to present validation progress, production metrics and compliance risks.

Manufacturing Process Engineer

Honda Auto Plant
, OH
03.2020 - 02.2021
  • Planned and coordinated manufacturing work orders in the facility and apply knowledge of the business to predict and plan for future manufacturing needs.
  • Assisted in compiling quality data, which includes gage R&R studies, process capability studies, trending of product defects, trending of functionality data for finished product, dimensions on components or finished product, raw material inspection/sampling, incoming component inspection.
  • Trained production and engineering staff on revised procedures and equipment start-up protocols to ensure safe, repeatable operations.
  • Created BI dashboard metrics for daily production to track key performance indicators (KPIs) like cycle time, throughput, control charts and downtime in real-time, allowing for immediate identification of bottlenecks and inefficiencies and implement cost reductions.
  • Coordinated with Line Supervisors, Technicians and Quality Engineers in developing and reviewing Work Instructions, pFMEAs, Quality plans, Maintenance procedures, Inspection plans, and specifications.
  • Develop, evaluate, and improve manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards.
  • Expertise in problem solving tools (DMAIC, 6M, Fishbone Diagrams, 5 Why’s, etc.) and statistical tools (Gage R&R) used during root cause investigations.
  • Analyzed and plan work force utilization, space requirements, and design layout of equipment and workspace for maximum efficiency and determine production times, staffing requirements.

Education

Master's - Aerospace Engineering

The University of Texas at Arlington
Arlington, TX, USA

Bachelor's - Aeronautical Engineering

Institute of Aeronautical Engineering
India

Skills

  • SolidWorks, Minitab, Agile PLM, Veeva Vault, ANSYS, Power BI, and MS Office (Word, Excel, PowerPoint)

Certification

  • SolidWorks (CSWA)
  • Six Sigma Green Belt (MSA)

Timeline

Senior Quality Engineer

Abbott
02.2021 - Current

Manufacturing Process Engineer

Honda Auto Plant
03.2020 - 02.2021

Master's - Aerospace Engineering

The University of Texas at Arlington

Bachelor's - Aeronautical Engineering

Institute of Aeronautical Engineering

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