Systems Design Quality Engineer

Job Title

Systems Design Quality Engineer

Job Description

Job Title: Systems Design Quality Engineer

Job Responsibilities:

• Guides the implementation of comprehensive process validation plans using statistical tools to ensure effective transition of new products to production, working under general supervision.
• Ensures the smooth execution of 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.
• Reviews and assesses the detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
• Proposes and initiates multiple quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle.
• Reviews and constantly evaluates product and system designs, guides the analysis of 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.
• Shares subject matter expertise and suggests proactive methods to strengthen risk management efforts, ensuring that risks are identified, assessed, and mitigated throughout the product lifecycle.
• Addresses and resolves quality engineering issues of medium to high complexity, applying established processes and policies to provide efficient resolutions.
• Suggests efficient utilization of post-market analytics to assess field performance, provide feedback to manufacturing and design teams, and implement field actions as necessary.
• Prepares for and support quality audits and inspections, ensuring all necessary documentation and processes are in place and compliant with internal and external standards.
• Applies continuous improvement techniques to enhance quality practices and maintain readiness for quality audits, ensuring adherence to both internal and external standards.

Minimum required Education:

Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent