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.***

• 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 resolve Top Issues from the field.
• Assess trending metrics, establish standardized reporting mechanisms, analyze results to identify emerging trends and improvement opportunities, and effectively communicate results through appropriate venues.
• Analysis of customer complaints related to manufacturing and product design, to include coordinating investigation and reporting of findings and recommendations.
• Collaborate with Operations staff to initiate, perform evaluations, and implement action plans to eliminate root causes of non-conformances.
• Collaborate with Supplier Quality and Supply Chain to drive projects and programs at Supplier sites.
• Participate in continuous improvement activities.
• Support the Master Validation Plan (MVPs) for Spacelabs products
• Support Validation and Verification activities across the organization.
• Act as the primary reviewer for Quality Engineering for Engineering Change Orders that support legacy products and processes.
• Develop and maintain Service MVPs
• Perform other related duties as required.
• Makes risk-based decisions as required to support corporate policies.
• Upholds the Company's core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrates behavior consistent with the Company's Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company's values, Code of Ethics and Conduct, and applicable compliance policies.
• It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

• Bachelor's degree in an engineering or related discipline, (Computer/Software, Biomedical, Mechanical, Electrical).
• 7+ years related Engineering / quality engineering experience.
• 5+ years of experience with medical device regulatory and quality systems.
• Experience supporting the implementation of Software as a Medical Device (SaMD) or Software within a device required.
• Experience reading, interpreting, and correcting CAD drawings/ schematics.
• Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation.
• Experience with statistical analysis and data mining.
• Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards.

#LI-Hybrid

Please review our benefits here:
The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location and date of hire. Please note that the salary information shown above is a general guideline only. Salaries are based upon candidate experience and qualifications, as well as market and business considerations.

NOTICE TO THIRD PARTY AGENCIES

OSI Systems, Inc. and its subsidiaries (collectively "OSI") does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

Equal Opportunity Employer - Disability and Veterans

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Poster Link: https://www.eeoc.gov/sites/default/files/migrated_files/employers/eeoc_self_print_poster.pdf

OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.