Summary
Overview
Work History
Education
Skills
Timeline
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Sandya Maloth

Summary

Experienced Quality Engineer with a strong background in medical device manufacturing, skilled at developing and maintaining quality specifications and inspection procedures to ensure compliance with industry standards and regulations. Proficient in implementing Advanced Product Quality Planning (APQP) methodologies to proactively identify and mitigate risks throughout the product development lifecycle. Skilled in conducting design reviews, root cause analysis, and process improvements to enhance product quality and regulatory compliance. Experienced in creating and updating standard operating procedures (SOPs) and APQP documentation, ensuring clarity and consistency in operations. Collaborative team player with a track record of supporting continuous improvement initiatives and driving efficiency gains through Lean and Six Sigma methodologies.

Overview

6
6
years of professional experience

Work History

Quality Engineer

Abbott
Alameda, CA
06.2023 - Current
  • Developed and maintained quality specifications for materials, components, and finished products, ensuring compliance with industry standards and regulations
  • Developed quality inspection procedures and sampling plans for production components and finished devices
  • Designed and modified process models to ensure compliance with FDA, ISO 13485, and other relevant medical device quality standards
  • Created and updated standard operating procedures (SOPs) for various quality-related processes, ensuring clarity and consistency in operations
  • Responsible for Implementing Advanced Product Quality Planning (APQP) methodologies to ensure proactive identification and mitigation of risks throughout the product development lifecycle
  • Conducted design reviews to evaluate product designs for manufacturability and quality, identifying potential issues early in the development process
  • Supported Manufacturing Engineering, and Operations in the design and manufacturing of medical devices in compliance with 21 CFR 820, ISO 14971, and GMP and regulatory requirements
  • Initiated procedural changes to improve quality management systems, manufacturing processes, and operating procedures
  • Implemented inspection control points throughout the manufacturing process to ensure product quality and compliance with specifications
  • Conducted Correlation and Regression Analysis, Experimental Design (DOE), Statistical Process Control (SPC), and capability analysis
  • Developed and maintained APQP documentation, including Quality Plans and Process Flow Diagrams
  • Conducted root cause analysis to identify the underlying causes of quality issues and implement corrective actions to prevent recurrence
  • Implemented process improvements to achieve cost savings, improve product quality, and meet customer requirements while maintaining regulatory compliance
  • Supported in creating and updating FMEA and risk management documents according to the new complaint trends and risk classifications, connecting complaints back to the hazard modes
  • Provided engineering support in the troubleshooting of process or product issues, including root cause failure analysis of discrepant materials and assemblies, including CAPA activities
  • Collaborated with procurement and supply chain teams to source materials and components that meet contract requirements and quality standards

Quality Engineer

Raytheon Technologies
Hyderabad, India
03.2019 - 07.2021
  • Responsible for Root Cause Analysis, Corrective and Preventive Actions (CAPA) reporting, handling, and closing of identified defects and findings
  • Generated quality reports for management review, providing insights into system performance and compliance
  • Evaluated testing data to ensure product specifications are met and DHR is compiled in a compliant manner, according to current cGMP and site SOPs
  • Conducted regular audits of inspection accountability systems to verify compliance with quality standards and regulatory requirements
  • Managed quality initiatives, ensuring compliance with FDA regulations and ISO 13485 standards
  • Managed Minitab for regression analysis to predict and control critical quality characteristics in medical device manufacturing
  • Utilized APQP methodologies to identify and mitigate potential quality risks in new product development projects
  • Maintained documentation of product analysis procedures, findings, and recommendations, ensuring transparency and traceability
  • Participated in Design for Manufacturability (DFM), Design For Assembly (DFA), and Process Failure Mode Effects Analysis (PFMEA) analyses
  • Supported continuous improvement initiatives, employing Lean and Six Sigma methodologies, resulting in enhanced process efficiency and product quality
  • Supported QMS compliance by performing acceptance activities, CAPAs, NCRs, process improvements, and operator training Root cause analysis
  • Provided support in conducting IQ, OQ, PQ, and Test method validation processes, ensuring compliance with CAPA requirements
  • Participated in continuous improvement projects to enhance the functionality and effectiveness of the quality metrics system
  • Collaborated with cross-functional teams to integrate APQP principles into the design, manufacturing, and validation processes

Education

Bachelors - Mechanical Engineering

JNTUH
Hyderabad, India

Masters - Computer Science

Campbellsville University
Louisville, USA

Skills

  • Quality management
  • Root cause analysis
  • Regulatory compliance
  • Risk assessment
  • Cross-functional collaboration
  • Problem solving
  • Effective communication
  • Standard operating procedures
  • Documentation management

Timeline

Quality Engineer

Abbott
06.2023 - Current

Quality Engineer

Raytheon Technologies
03.2019 - 07.2021

Bachelors - Mechanical Engineering

JNTUH

Masters - Computer Science

Campbellsville University

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