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The Design Quality Engineering Team is tasked with a dual role as an embedded member of project teams to provide expertise and guidance on the Risk Management process as it relates to our quality management system and product safety, and the role of independent oversight to ensure that Philips designs live above the common level and meet the spirit and the letter of the policies that guide product team for safe inherent design
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/ Vocational Education. Minimum required Experience:
Bachelor's degree with minimum 4 years of experience in Quality Engineering, Safety Engineering, R&D Engineering or equivalent with Vocational Education. Minimum required Certification:
N/A Preferred Education:
N/A Preferred Experience:
N/A Preferred Certification:
Six Sigma Green Belt Preferred Skills:
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
