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 Senior Quality Engineer will be responsible for performing quality engineering support for product design and manufacturing teams, providing support to Spacelabs' technical compliance capabilities according to local, national, and international standards; driving initiatives and projects to enhance quality performance within Design Control and Manufacturing; developing and maintaining processes related to Design Quality Engineering to ensure compliance with all relevant standards, laws and regulations; assisting with testing and root cause analysis to troubleshoot design and change control issues; using statistical process control to improve Design Quality Engineering; ensuring technical documentation is maintained; and implementing a proactive program to monitor and address changes in global requirements. This position is located in Snoqualmie, Washington. It is a HYBRID role, with the expectation of 3 days per week in the office, and flexibility to come in for meetings or audits as needed. Responsibilities Supporting the development teams of all business areas, working within the project teams on new or sustaining product development projects. Drive continuous improvement in development and manufacturing processes. Support the remediation and maintenance of all Technical Documentation Files. Support the maintenance of the Essential Requirements Checklists / General Safety and Performance Requirements checklist. Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH, and Global regulatory requirements applicable to Spacelabs' products supporting the manufacturing teams of all business areas, working within the teams on new or sustaining product improvements. Perform Manufacturing floor walkthroughs. Executes Corrective and Preventive Action (CAPA), including root cause identification, action planning, reporting, and completion of remedial action plans. Trains other team members on the CAPA process. Facilitates an effective Internal Quality Audit program: Plan, perform, and document internal audits. Drive compliance activities and improvements, covering, but not limited to, risk management, design and development, safety, manufacturing, purchasing, process control, labeling, usability, and service. Supports and/or facilitates quality system tool updates (Computer System Validation plan, protocol, report). Drive product continuous improvement efforts for legacy products and processes: Utilizes measurement system analysis (MSA) to track product quality, to include Statistical Process Control (SPC), I-charts, or other methodologies, as well as identifying quality opportunities associate with Product Failure Methods and Effects Analysis (PFMEA) and Control Plans. Makes quality decisions on products of questionable quality, safety, or efficacy based on drawings, specifications, fit, functionality, testing, risk assessment, customer requirements, and postmarket surveillance data. Gathers and presents product quality performance statistics on a regular basis. Initiates and leads the development of test methods, tooling, techniques, and procedures for parts analysis and investigation. Advises management on quality-related continuous process improvement opportunities for Design and Change Control and manufacturing. Perform investigations to identify and eliminate the cause of product and process nonconformances. Drive programs and projects to reduces product Field Failure Rate, address Hot Topics, and