Sr. Quality Assurance Engineer

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!

At Spacelabs Healthcare, you make a difference.

Every member of our worldwide team is integral in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit yearly from the advancements we make in patient monitoring and management, care coordination, and clinical decision support.

Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being, and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.

While we may not be at a patient’s bedside, their health is still in our hands.

The Sr. Quality Assurance Engineer is responsible for the establishment, maintenance, operation, and effectiveness of the Spacelabs Quality Management System. The 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.

Sr. 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 is achieved by inspiring employees to reach their potential, fostering teamwork, and demonstrating operational excellence through leadership to support company quality policies and goals.

This is a hybrid position requiring employees to work 3 days/ week at our headquarters in Snoqualmie, WA.

• Design Control
  • Provide Quality System Design Control mentoring to ensure product design teams’ use of critical thinking. 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 offer 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 (MRB)
  • 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 backlog.
• Installation and Service
  • Ensure post‑market activities confirm 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
  • Conduct 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
  • Ensure high quality of products and services by implementing and maintaining the…