Varshita Achanta
Warsaw,IN
Summary
Engineering Professional with focus on providing Quality Engineering support primarily to the Solutions Operations through line support, continuous improvement, capacity improvements and new product transfers. Improve the overall efficiency of the manufacturing operation while optimizing human work factors, quality control, material flow, and manufacturing process by identifying areas for improvement using statistics and root cause analysis tools. Experienced in reviewing and interpreting regulatory guidance, risk management, complaints handling and corrective action programs. Other responsibilities include manufacturing processes development, integration of lean manufacturing concepts into the organization, and project planning.
Overview
1
1
year of professional experience
Work History
Manufacturing Engineer
Zimmer Biomet
05.2023 - Current
- Addressed NC issues in manufacturing operations with expertise in Root Cause analysis, Corrective Actions, and Issue Evaluations
- Supported the team on corrective actions and preventive actions
- Develop and execute validation protocols (IQ/OQ/PQ) to verify and validate manufacturing processes
- Led continuous improvement through Kaizen events, driving innovation, reducing costs, and improving overall efficiency
- Provide training to production staff on new processes and technologies, ensuring skill development and knowledge transfer
- Assisted in corporate audit through efficient proceedings transcription, contributing to accurate reporting and compliance
- Managed, edited, and optimized manufacturing routers for precision, compliance, operational efficiency, and traceability, resulting in reduced lead times
- Worked in cleanroom environment to reduce the non-conformances in various part families
- Reduced contamination risks by strictly adhering to cleanroom protocols and standard operating procedures.
Development Quality Engineer
Abbott Laboratories
07.2022 - 12.2022
- Wrote, Reviewed and approved Engineering Change Orders and Engineering Change Records, Graphics, Product Development History documents, IQ, OQ, PQ for accuracy and correctness
- Reviewed product and process control methods documents to ensure that criteria for identifying critical control points are met
- Conducted various test methods to qualify the supplier for different parts of pacemakers
- Received and reviewed product batch records and product batch files
- Supported Supplier management activities including approvals, Nonconforming Materials, Deviations, Change requests, and supplier performance
- Identified and coordinated activities required to complete qualification and validation activities, including reviews with Quality, obtaining signature approvals, and executing qualification protocols or validation project plans
- Responsible for providing quality management team with audit results and lead in closing out corrective action issues
- Interfaced with management, peers, and subordinates to assess and improve adequacy of processes, which includes but not limited to remediation efforts of CAPA, Complaint, and Nonconformity (NC) deficiencies identified in internal audits and/or inspections
- Effectively adapted to customer needs, processes, requirements, and cultures as required when involving different areas (QA, Clinical Packaging, Materials Management, Project Management, Global Clinical Supply Operations (GCSO) and Ludwigshafen (LU) Global Drug Supply Management (GDSM)) within investigations
- Hands on experience with working in clean room environment for testing the pacemaker samples and testing molded components
- Ability to understand process maps, safety expectations, quality systems and regulatory requirements of a FDA regulated facility
- Ability to ensure master validation plan and master calibration plan is up to date and being implemented in timeframes
- Reviewed and modified product design and process documentation for reliability and to comply with quality requirements
- Hands on experience on product compliance for sterilization, biocompatibility, shelf life, reliability and electrical safety of different pacemakers
Education
B.Tech in Mechanical Engineering -
Reva University
M.S. in Mechanical Engineering -
University of South Florida
Skills
- Geometric Dimensioning & Tolerance (GD&T)
- Gage R&R, Capability studies and SPC
- Matlab
- Application and Usage of Six-Sigma Tools
- Continuous Process Improvement
- JD Edwards
- Enovia
- Windchill
- Quality System Audits (internal and Supplier)
- Solid Works and AutoCAD
- Quality control plans
- Minitab
- Design for Manufacturability (DFM)
- FEA and failure analysis
Accomplishments
- Influence of process parameters on mechanical properties of AlSi10Mg produced by Selective Laser Melting
- Developed a 6 Degrees of Freedom Robotic arm.
- Varshita Achanta (01/2022). IMECE2021 Paper - Data Driven Multi-Criteria Decision-Making for Smart and Sustainable Machining
Languages
English
Full Professional
kannada
Native or Bilingual
Tamil
Native or Bilingual
Telugu
Native or Bilingual
Hindi
Native or Bilingual
Spanish
Elementary
Timeline
Manufacturing Engineer
Zimmer Biomet
05.2023 - Current
Development Quality Engineer
Abbott Laboratories
07.2022 - 12.2022
B.Tech in Mechanical Engineering -
Reva University
M.S. in Mechanical Engineering -
University of South Florida
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