RESPONSIBILITIESWork closely with R&D to assess and influence product designs for quality, reliability and regulatory compliance.Evaluate schematics, PCB layouts and hardware specifications to identify potential design-related quality risks and ensure robust engineering standards are met.Lead design risk assessments (e.g., DFMEA) and support root cause analysis for design-related issues.Support NPI validation and verification strategies.Support Purchasing team and R&D teams with New Vendor and part approvals processes with a focus on ensuring quality is maintained.Statistical analysis and reporting of parametric test data.Support software and hardware testing from a quality perspective.Provide technical support to Production, Test departments and Process Quality Engineers in resolving product-related issues, ensuring effective communication between R&D and operations.Ensure traceability and compliance with regulatory and internal standards.Drive continuous improvement in design processes and quality metrics.Act as a technical quality representative in design reviews and product development meetings.Support audits and regulatory inspections related to design controls.REQUIREMENTSBachelor’s Degree in engineering (Electronic, Electrical, Software, or related).5+ years in a Quality or R&D role within a regulated industry (e.g., medical devices, aerospace, automotive, life safety).Strong understanding of product development, lifecycle and design controls.Experience with hardware/software integration and testing.Familiarity with ISO 9001, or similar standards.Ability to read and understand electronic schematics and circuit designs.Experience with FMEA, risk management and root cause analysis tools.Knowledge of embedded systems, firmware, or software development.Strong communication and cross-functional collaboration skills.Ability to interpret technical drawings, specifications, and test data.
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