Senior Quality Engineer of Design Quality

Universal DX, Inc. is an international company focused on early cancer detection through innovative diagnostic tests. The Senior Design Quality Engineer will support the design, development, and regulatory approval of a colorectal cancer screening test, ensuring quality control and compliance with regulatory standards.

Responsibilities:

• Review software and assay protocols, reports, and related documentation to ensure all changes are properly verified and that assay, software, equipment, and facilities are validated in accordance with design controls and Quality System requirements
• Proactively identify, document, and communicate variances or anomalies identified during reviews to Quality Management in a timely manner
• Resolve minor protocol variances through collaboration with appropriate Subject Matter Experts (SMEs) to ensure compliant and timely resolution
• Collaborate cross-functionally with Assay, Software, Facilities, and Engineering teams to investigate and resolve anomalies identified during design and development execution
• Support facility and equipment qualification activities (IQ/OQ/PQ), including review and approval of qualification protocols and reports to ensure systems are fit for intended use and compliant with regulatory requirements
• Demonstrate working knowledge of Software Design History File (DHF) requirements, including review of software lifecycle documentation to ensure traceability, risk management, and design control compliance
• Review and support test method validation and verification activities, ensuring methods are scientifically sound, properly documented, and suitable for their intended use
• Identify opportunities for improvement and update SOPs and associated forms to maintain continuous compliance with the Quality Management System (QMS) and applicable regulatory standards
• Ensure alignment with project timelines by completing reviews and approvals within established deadlines
• Assist in the development, implementation, and maintenance of departmental procedures in compliance with FDA Quality System Regulations (QSR), ISO standards (ISO 13485, ISO 14971), and 21 CFR Part 11
• Maintain thorough knowledge of and adherence to applicable policies, procedures, and regulatory requirements related to assigned responsibilities
• Work independently with objectives and priorities provided by Quality Assurance Management
• Plan, prioritize, and coordinate work activities in alignment with higher-level project schedules
• Execute quality-related tasks in full compliance with current Quality System requirements

Requirements:

• Bachelor's degree in Life Sciences or Engineering or a related field
• More than 5 years of experiences in a Quality Role, OR an equivalent combination of education, training, and/or experience
• More than 3 years of experience working with FDA approved, OR an equivalent combination of education, training, and/or experience
• Strong working knowledge of Design History File (DHF) requirements
• Experience with risk management, test method validation, software lifecycle documentation, and verification and validation activities across assay, software, equipment, and facilities
• Ability to collaborate cross‑functionally with Assay, Software, Engineering, Facilities, and Regulatory teams
• Experience in supporting facility and equipment qualification activities (IQ/OQ/PQ)
• Knowledge of FDA Quality System Regulations (QSR), ISO standards (ISO 13485, ISO 14971), and 21 CFR Part 11
• Ability to work independently with objectives and priorities provided by Quality Assurance Management
• Ability to plan, prioritize, and coordinate work activities in alignment with higher-level project schedules