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Job Description Overview At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients. Why work at Spacelabs? Because lives depend on you! The Lead (Senior) Quality Assurance Engineer is responsible for the establishment, maintenance, operation, and effectiveness of the Spacelabs Quality Management System. The Quality Management System (QMS) is intended to ensure effective and efficient operation of the organization, including assurance of the quality of the products and services offered by Spacelabs. Lead Quality Assurance Engineers are responsible for maintaining a quality- and results- centric company culture that drives customer satisfaction, employee satisfaction, meaningful regulatory compliance, and continually improving operational excellence. This shall be done by inspiring employees to achieve to their potential, fostering the achievement of company goals by organized teamwork, and demonstrating operational excellence via leadership to support company quality policies and goals. They also seek to maintain operations that efficiently and effectively surpass strategic business planning and performance objectives. *Preference will be given to local candidates, but we are open to non-local/ remote candidates as well. * Responsibilities The Sr. Quality Assurance Engineer will provide leadership and support for QMS performance in many facets of business operations: Design Control To ensure the release of safe, effective and compliant medical devices, the Sr. Quality Assurance Engineer shall provide Quality System Design Control mentoring to ensure product design teams' use of critical thinking. They will be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. Ensure the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance. Review all Engineering Change Orders and proposed changes or improvements to ensure sound engineering practice, effective and adequate design, product safety, and Quality System compliance. Ensure product Design Change activities move ahead in a timely and effective manner. Manufacturing Monitor and ensure efficient and effective product manufacturing processes, facilitating adequate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling. Material Review Board Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Process performance metrics shall be captured, monitored, and reported to ensure timely and effective MRB throughput and minimized quarantine back log. Installation and Service Ensure post-market activities ensure intended device performance. Service and support activities must be adequately documented, attention escalated to facilitate defect handling, and product performance and performance trends assessed to understand and drive improvement opportunities. QMS Administration Responsible for conducting QMS administration activities, including Internal Quality Audits, Corrective and Preventive Action, Process Change Control, Exception Handling, process improvement and maintenance, supplier quality, external audit support, and related activities. Responsibilities & Goals The Sr. Quality Assurance Engineer shall follow the guidance of RA/QA Management and help other organizational functions understand and fulfill their obligations to meet quality objectives, syst