Quality Engineer

Help shape quality at a defining moment for point-of-care diagnostics. In March 2026, Lumos Diagnostics achieved a transformative milestone: FDA 510(k) clearance with CLIA waiver for FebriDx®. The approval expands access to more than 300,000 healthcare locations and advances Lumos into its next stage of U.S. commercial growth. As our opportunity grows, we are investing in the people and expertise needed to scale with quality. We are seeking a hands-on Quality Engineer III who wants to be close to where products are made, challenges are solved, and meaningful improvements take hold. This addition-to-staff position will serve as a senior quality partner to Manufacturing and Operations, helping strengthen product quality, improve processes, and build the systems needed to support Lumos’s continued growth. If you are energized by complex problem-solving, data-driven decision-making, and the opportunity to make a visible impact in a growing diagnostics company, this may be the opportunity for you. Lumos develops, manufactures, and distributes innovative diagnostic products—delivering actionable information, in real time, at the point of care. Our work is driven by a shared mission and four core values: Take Ownership. Engage Openly. Act with Integrity. Move Together. These values shape how we solve problems, work across teams, and deliver solutions that can make a meaningful difference for healthcare professionals and their patients. Learn more about the FebriDx milestone:FDA CLIA Waiver for FebriDx unlocks US$1B+ U.S. opportunity The Opportunity Reporting to the Vice President of Quality, the Quality Engineer III will serve as a senior technical resource for manufacturing and operational quality. You will work directly with Manufacturing, Operations, Product Development, Regulatory Affairs, Supply Chain, Technical Services, and Quality colleagues to solve operational challenges, strengthen quality performance, and ensure our products consistently meet customer, company, and regulatory requirements. This is not a desk-bound quality role. You will be present on the manufacturing floor, engaged in investigations, and actively involved in translating quality data into practical action. The position does not initially have direct reports; however, it will provide day-to-day technical leadership, mentoring, work direction, and coordination for QA/QC personnel. Future supervisory responsibilities may be considered as the organization grows and based on demonstrated performance. What You’ll Own Serve as the primary quality lead for manufacturing operations, process performance, product release, manufacturing readiness, and continuous improvement. Work directly on the manufacturing floor to resolve quality issues, support production, and provide technical guidance during troubleshooting and process improvements. Lead complex investigations involving nonconformances, manufacturing deviations, supplier issues, customer complaints, and product failures. Develop, implement, and verify corrective and preventive actions that address root causes, reduce risk, and deliver sustainable results. Analyze manufacturing, supplier, complaint, audit, and nonconformance data to identify trends, prioritize risk, and recommend action. Develop inspection methods, acceptance criteria, sampling plans, and quality standards that improve yield, reduce defects, and strengthen product quality. Lead supplier investigations, supplier corrective actions, performance trending, and improvement activities in partnership with Supply Chain and Operations. Support facility transfers, equipment qualifications, process validations, manufacturing scale-up, and new product introductions. Participate in supplier and internal audits, customer audits, and regulatory inspections while supporting compliance with ISO 13485, FDA Quality System Regulation requirements, and other applicable standards. Provide technical leadership and practical mentoring to QA/QC personnel while helping cross-functional teams move critical work forward. What Success Looks Like Quality issues are identified early, evaluated thoughtfully, and resolved without compromising product, customer, or regulatory requirements. Investigations and CAPAs are rigorous, timely, and supported by evidence that corrective actions are effective and sustained. Quality data gives teams and leaders a clear view of performance, emerging trends, and areas of risk. Manufacturing, validation, scale-up, and facility-transfer activities are supported through strong quality planning and execution. Cross-functional teams experience Quality as a credible, engaged, and solutions-oriented partner. What You Bring A bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Quality Engineering, Life Sciences, or a related technical discipline. Four to seven years of progressive Quality Engineering experience in medical devices, in vitro diagnostics, biotechnology, pharmaceuticals, or another regulated manufacturing industry. Hands-on experience supporting manufacturing quality operations, inspections, nonconformance disposition, product release, and supplier quality. Demonstrated experience leading investigations, CAPAs, nonconformance management, and root-cause analysis. Strong working knowledge of ISO 13485, FDA Quality System Regulation requirements, and applicable regulatory standards. Experience developing inspection methods, acceptance criteria, sampling plans, or quality standards. Working knowledge of structured problem-solving and quality tools such as FMEA, 8D, Fishbone, 5 Whys, SPC, Pareto analysis, statistical analysis, Lean Manufacturing, and continuous improvement methods. Experience leading cross-functional projects and providing technical leadership, work direction, or mentoring to quality personnel. Strong technical writing, communication, project-management, and collaboration skills. Proficiency with Microsoft Office and electronic quality management systems. Experience That Would Set You Apart Experience supporting CLIA-waived or point-of-care diagnostic products. Experience supporting FDA inspections, ISO 13485 certification audits, or MDSAP audits. A master’s degree in Engineering, Quality, or Business Administration. ASQ Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, or Lean Six Sigma Green Belt or Black Belt certification. Why Join Lumos? This is an opportunity to join Lumos at an important point in our growth and help shape how quality supports what comes next. Your work will influence manufacturing performance, strengthen quality systems, improve how teams solve problems, and support diagnostic products designed to deliver actionable information when and where it is needed. The work is hands-on. The impact is visible. And the mission matters. If you are ready to bring your technical expertise, sound judgment, and commitment to quality to a collaborative team building the future of point-of-care diagnostics, we would like to hear from you. Compensation and Benefits The annual base salary range for this position is $111,000–$120,000. Actual compensation will be determined based on experience, qualifications, internal equity, and business considerations. Lumos Diagnostics offers a competitive benefits package, including: Medical, dental, vision, life insurance, and disability coverage 401(k) with employer match Paid time off, paid holidays, and sick time Work Environment and Physical Requirements This is a full-time, on-site position in Carlsbad, California. Regular presence in manufacturing, quality-control, and laboratory environments is required. Remote or hybrid work is not available for this role. The position frequently requires standing, walking, sitting, and using hand and finger dexterity. It occasionally requires bending, stooping, kneeling, crawling, climbing, balancing, or lifting or moving more than 30 pounds. The work environment may involve exposure to bloodborne or airborne pathogens or infectious materials. Appropriate personal protective equipment and safety practices are required. Lumos Diagnostics is an equal opportunity employer. #J-18808-Ljbffr Lumos Diagnostics