Design Quality Engineer

Systems Design Quality Engineer, 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. Minimum required Education: High School Diploma, Vocational Education/ Bachelor's Degree in or equivalent. Minimum required Experience: Minimum 2 years of experience with Vocational Education in Quality Engineering, Safety Engineering, R&D Engineering or equivalent OR no prior experience with Bachelor's Degree. 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) 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, Current headcount cannot properly support a new product initiative (SmartSweep). Therefore, a contingent worker is being requested for this project with funding for this role to come from the Gates Foundation.