Senior Quality Engineer of Design Quality

The Opportunity: 

 Universal DX is seeking a Senior Design Quality Engineer to join our growing Design Quality team, supporting the design, development, and regulatory approval of an innovative screening test for colorectal cancer. This role will be instrumental in the quality review, oversight, and approval of design control deliverables, including analytical validation (AV) studies, software and assay documentation, and associated protocols and reports used to characterize test performance. 

This position is intended for a Design Quality professional with direct experience supporting FDA PMA programs. The role requires strong working knowledge of Design History File (DHF) requirements, risk management, test method validation, software lifecycle documentation, and verification and validation activities across assay, software, equipment, and facilities. 

The Senior Design Quality Engineer will collaborate cross‑functionally with Assay, Software, Engineering, Facilities, and Regulatory teams to identify and resolve anomalies, protocol variances, and validation issues, while ensuring timely reviews, approvals, and alignment with project schedules. The role also supports facility and equipment qualification activities (IQ/OQ/PQ) and contributes to the continuous improvement of SOPs and Quality System processes to maintain inspection readiness. 

This position may be performed remotely within the U.S., with regular cross-functional engagement, or on-site as needed to support laboratory execution, qualification activities, or critical development milestones. 

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”. 

How you’ll contribute: 

• 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. 

What you’ll bring: 

• 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. 

What we´ll offer: 

We’re proud to offer exceptional corporate benefits which include: 

• 22 days of PTO with the possibility to carry over 10 days to the following year.  

• Company Holidays, plus your Birthday off!   

• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).  

• Flexible work schedule   

• And more to come!