**Position Summary** Staff Operations Quality Engineer provides quality assurance support for all aspects of manufacturing operations, including process quality, QC testing, inspections (incoming, in-process and final), validations, supplier quality, DMR/DHR creation and maintenance and various QMS activities through the operations lifecycle. Furthermore, this role focuses on establishing strategies for quality engineering, inspection & testing, suppliers and supply chain activities to achieve operational excellence. The role collaborates and builds relationships with cross-functional stakeholders such as Laboratory Operations, Supply Chain, Supplier Quality, Equipment, Facilities, EH&S, Quality Assurance, Quality Control and QMS teams to develop ideas and use cases and industry best practices in the implementation of manufacturing operations in a hybrid (diagnostic/IVD and clinical/CLIA/CAP/LDT) laboratory environment. **Job Responsibilities** + Process and Production Controls: Work closely with laboratory/manufacturing operations and other functions to ensure quality performance of product workflows and associated processes. Capture process knowledge to facilitate subsequent process validation activities. + Process Monitoring: Continuously monitor and analyze production processes, identifying potential failure modes, risks, and controls, and opportunities for improvement and implementing corrective and preventive actions. + Process Improvement: Modify methodologies and procedures, ensuring continuous improvement of processes. Employ statistical analysis, and problem-solving techniques to drive product quality improvements, minimize defects, and enhance overall performance. + NPI/Manufacturing Transfer: Provide quality engineering support to Product Development, Translational Sciences, Design Quality Teams for NPI programs. Support process development and process characterization and ensure the efficient and timely transfer of process knowledge and quality systems knowledge to Laboratory (Manufacturing) Operations. Support the creation of DMR and DHR for new medical device/IVD products. + Risk Assessment: Partner with Risk Management team to conduct thorough risk assessments, utilizing tools such as FMEAs, to proactively identify and address potential product or process risks. + QC Inspection and Testing: Support Supply Chain for incoming material, in-process and final product release. Oversee incoming inventory material receiving records, and quality control testing documentation to release the materials for production use. Review, sign-off and release of kit, batch and other manufacturing records to ensure the completeness of DHRs. Support the development of material specification and incoming inspection process including test method development and test method validation. Lead investigations of complaints, non-conforming products and materials to identify root causes and determine appropriate disposition through MRB. + Supplier Quality: Support supplier quality initiatives to maintain a robust supplier quality program. + QMS and Change Controls: Support change management activities throughout product life cycle as applicable to Operations (sustaining engineering/value engineering). Support CAPAs, deviations and other QMS activities. Ensure adherence to GDP, GMP, EH&S and other applicable procedures to manufacturing. + Regulatory Compliance: Drive a customer (internal and external) centric quality culture and maintain compliance to applicable standards, regulations and internal QMS requirements. Support audit preparation strategy and execution. Participate and interface with internal & external audits with the QA team. Responsible for initiation, internal containment, communication, and support of commercial holds for potential non-conforming product (Quarantine/MRB/ NC). + Operational Excellence: Provide mentorship and guidance to other operations quality team members, fostering a culture of growth, continuous improvement and Quality expertise within the department. Coordinate the training of Laboratory personnel, Quality Engineers and related personnel on various manufacturing procedures, Quality System regulations, etc. Support scalability of enterprise systems including LIMS, ERP, eQMS, etc. + Inter-Organization Collaboration: Build productive and collaborative internal/ external professional relationships across various teams and functions associated with Laboratory/Manufacturing Operations, Supply Chain, Supplier Quality, Equipment, Facilities, EH&S, Quality Assurance and Quality Control activities. + Other duties and responsibilities as assigned. **Required Qualifications** + B.S. in Engineering, engineering related discipline or equivalent experience. + 5+ years in Quality Assurance or related functional area preferably in the IVD or medical device manufacturing environment or CLIA/CAP/LDT/clinical laboratory operations. + Development and implementation of production and process controls (i.e. PDCA, DMAIC experience). + Demonstrated knowledge of improvement and statistical tools/techniques used within process excellence activities. + Expert knowledge of process monitoring, quality assurance, quality engineering and quality control methodologies. + Experience in executing problem solving techniques related to manufacturing/design technical issues. + Proven ability to drive and develop improvement of critical business metrics. **Preferred Qualifications** + ASQ-CQE, CQA experience desired. + Minimum 3 years of experience with transferring products from design phase to production phase. + Knowledge of Lean Supply Chain, Six Sigma, and other defect reduction and efficiency building tools and methodologies such as kaizen, kanban, value stream mapping, etc. + Knowledge of regulations pertaining to, or experience working in, clinical/CLIA/CAP/LDT and/or diagnostic/FDA/IVD labs is a plus. + Knowledge of ISO 13485 and ISO 14971, FDA Quality System Regulation 21 CFR Part 820 or cGMP is a plus. + Experience in supporting FDA inspections as a quality SME and an ability to interpret regulatory requirements. + Working knowledge of CAPA process and change management process. + Experience in project management and risk management techniques. + Capability to work with diverse teams and personalities. Great listening and influencing skills. Ability to coach/teach others. **Physical Demands** + Employee may be required to lift routine office supplies and use standard office equipment. Ability to sit for extended periods of time. Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment. **Training** + All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. **Other** + This position requires periodic travel and some evenings, weekends and/or holidays. + Job may require after-hours response to emergency issues. + Periodically scheduled on-call may require after-hours response for technical emergencies not explicitly related to assigned job responsibilities. + At times may be required to work weekends/holidays. **Conditions of Employment:** Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.