Job Title
QAQE for Products and Systems
Job Description
Job title:
QAQE for Products and Systems
Your role:
- 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 effective 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 contin
📌 QAQE for Products and Systems (Pune)
🏢 Philips
📍 Pune