Quality Systems Engineer

Quality EngineerVarian Medical Systems, a Siemens Healthineers company, is seeking a Quality Engineer to join our team in Austin, Texas. As the site's primary quality engineering resource, you will have the opportunity to contribute to important engineering decisions and directly support manufacturing operations, incoming inspection, supplier quality, quality systems, and continuous improvement activities within an ISO 13485:2016 compliant manufacturing environment.Working closely with Supply Chain, Engineering, Regulatory Affairs, IT, and other cross-functional teams, the Quality Engineer will help develop, implement, and sustain scalable quality practices that ensure product quality, process effectiveness, regulatory compliance, and operational excellence.The Quality Engineer will provide hands-on support for manufacturing quality, nonconformance and CAPA processes, quality systems administration, and operational improvement initiatives. Leveraging quality engineering tools, data-driven decision-making, and structured problem-solving methodologies, this role will identify risks, drive corrective and preventive actions, and establish practical, sustainable quality controls that support the continued growth and success of the Austin, TX operation.What You Will Do:Serve as a key quality engineering resource across quality systems, and operational excellence initiatives.Define, implement, maintain, and continuously improve quality system processes, procedures, work instructions, and other related controlled documentation to support Austin operations and ISO 13485:2016 compliance.Support manufacturing operations by ensuring products, processes, and quality controls meet established specifications, regulatory requirements, and customer expectations.Investigate, document, and support the timely closure of nonconforming materials, components, processes, and finished goods while partnering with Operations, Engineering, Supply Chain, and other stakeholders to drive timely resolution.Lead and support root cause investigations, containment actions, corrective and preventive actions (CAPA), and recurrence prevention efforts using structured problem-solving methodologies.Analyze quality system data to identify trends, mitigate risks, and drive data-based improvements.Establish, monitor, and report key quality performance indicators, including yield, defect trends, supplier performance, inspection effectiveness, calibration compliance, and issue closure metrics.Support new product introductions, manufacturing readiness activities, process changes, equipment qualification, risk assessments, process validation, and production builds as needed.Participate as needed in internal audits, management reviews, document control activities, and other quality system processes to ensure site compliance and audit readiness.Partner closely with Operations, Manufacturing Engineering, Supply Chain, Product Quality, Supplier Quality, Quality Systems, and site leadership to resolve quality issues, strengthen process controls, and enhance customer satisfaction.Apply Lean, Six Sigma, statistical methods, and continuous improvement tools to reduce variation, improve yield, lower the cost of poor quality, and drive operational excellence.What You Will Have:Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality, or a related engineering discipline, with 2+ years of experience in a quality, manufacturing, or process engineering role.Experience supporting manufacturing operations, establishing Quality Management Systems (QMS), quality investigations, and continuous improvement initiatives.Working knowledge of ISO 13485:2016 or similar quality management system requirements.Experience using structured problem-solving and root cause analysis methodologies to investigate and resolve quality issues.Strong analytical skills with the ability to interpret data, identify trends, and drive effective corrective actionsWhat Will Set You Apart:Experience in an ISO 13485:2016 and/or regulated manufacturing environment.Experience in establishing a Quality Management System (QMS), supporting investigations, audits, and other elements of quality systems activities.Working knowledge of calibration and metrology systems, equipment qualification, process validation, and statistical quality methods.Familiarity with continuous improvement and problem-solving methodologies, including Lean Manufacturing, Six Sigma, SPC, FMEA, and 8D.Experience with SAP, ERP systems, electronic quality management systems (eQMS), and quality reporting or analytics tools.ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt, or equivalent professional certification preferred.Broad quality engineering experience spanning manufacturing, incoming inspection, supplier quality, and quality systems.A practical, hands-on approach to improving processes, solving problems, and supporting manufacturing operations.Demonstrated success building scalable quality processes, controls, and systems in a dynamic manufacturing environment.Strong collaboration and influencing skills, with a track record of driving sustainable improvements in quality, compliance, and business performance