System Design Quality Engineer

Role- Systems Design Quality Engineer

Experience - 2yrs to 4 yrs

Location - Bangalore and Pune

Contact to hire position with product base company

Interested candidate can share profile on below -

juhi.srivastava@randstad.in

k.minakshi@randstad.in

Mandatory Skill Required

• Design Quality Management
• Data Analysis & Interpretation
• Design for Quality (DFQ)
• 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

Job Responsibilities

• Helps to implement comprehensive process validation plans using statistical tools to ensure effective transition of new products to production, working under direct supervision.
• Participates in 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.
• Updates and maintains detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
• Supports in the execution of quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle.
• Helps to evaluate product and system designs, reviews performance data, and performs root cause analysis to address quality deficiencies and ensure design excellence.
• Ensures validation of essential design inputs such as usability, reliability, performance, manufacturability, and safety, aligning with quality standards and regulatory requirements. Contributes to risk management efforts, ensuring that risks are identified, assessed, and mitigated throughout the product lifecycle.
• Addresses and resolves quality engineering issues of low to medium complexity, applying established processes and policies to provide efficient resolutions.
• Utilizes post-market analytics to assess field performance, provide feedback to manufacturing and design teams, and implement field actions as necessary.