Design Quality Engineer

We are seeking a skilled and detail-oriented Design Quality Engineer to join our team in CA,The ideal candidate will have strong experience in design quality within the medical device or regulated industry, with a solid understanding of design controls, risk management, and product lifecycle processes. This role will play a critical part in ensuring product quality and compliance throughout the design and development phases. Key Responsibilities: Support design control activities in compliance with FDA 21 CFR Part 820 and ISO 13485 requirements. Partner with R&D teams during product development to ensure quality is built into the design. Participate in design reviews and provide quality input throughout the product lifecycle. Develop and maintain Design History Files (DHF) and ensure proper documentation practices. Perform risk management activities in accordance with ISO 14971, including risk analysis and mitigation. Review and approve design verification and validation protocols, reports, and test methods. Ensure traceability between user needs, design inputs, outputs, and verification/validation activities. Support change control processes and assess the impact of design changes. Drive root cause analysis and support CAPA activities related to design issues. Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory, and Supplier Quality. Ensure compliance with applicable regulatory standards and internal quality systems. Required Qualifications: Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field). 4+ years of experience in Design Quality Engineering within medical device or regulated industry. Strong knowledge of design controls, design assurance, and product development lifecycle. Hands-on experience with DHF, risk management (ISO 14971), and design verification/validation. Familiarity with FDA 21 CFR Part 820, ISO 13485, and other applicable standards. Experience with CAPA, root cause analysis, and change control processes. Strong documentation, analytical, and problem-solving skills. Excellent communication and cross-functional collaboration abilities. #J-18808-Ljbffr