Systems Design Quality Engineer

Overview

Quality engineering role supporting process validation, design control, quality documentation and post-market analytics for product and system design.

What you'll do

• Facilitate implementation of comprehensive process validation plans using statistical tools to ensure effective transition of new products to production, working under direct supervision.
• Execute the design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer, ensuring full compliance with regulatory and quality standards.
• Produce and maintain detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
• Execute quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle.
• Participate in the evaluation of product and system designs, review performance data, and perform root cause analysis to address quality deficiencies and ensure design excellence.
• Ensure validation of essential design inputs such as usability, reliability, performance, manufacturability, and safety, aligning with quality standards and regulatory requirements.
• Provide expertise and contribute to risk management efforts, ensuring that risks are identified, assessed, and mitigated throughout the product lifecycle.
• Address and ensure resolution of quality engineering issues of low to medium complexity, applying established processes and policies to provide efficient resolutions.
• Utilize post-market analytics to assess field performance, provide feedback to manufacturing and design teams, and implement field actions as necessary.
• Prepare for and support quality audits and inspections, ensuring all necessary documentation and processes are in place and compliant with internal and external standards.

What you'll need

• Minimum required education: Bachelor's Degree.
• Minimum 3-4 years of experience in Quality Engineering, Safety Engineering, R&D Engineering.

Nice to have

• Six Sigma Green Belt certification.
• Design Quality Management.
• Data Analysis & Interpretation.
• Design for Quality (DFQ).
• Root Cause Analysis (RCA).
• CAPA Methodologies.
• Regulatory Requirements.
• Privacy, Safety and Security Risk Assessment.
• Technical Documentation.
• Continuous Improvement.
• Product Quality and Reliability.
• Defect Management.
• Design Verification Planning.
• Design Validation Planning.
• Product Test Design.

Details

• Location: Bangalore.
• Office-based teams work in-person at least 3 days per week.