Job at a glance
Overview The Sr. Quality Assurance Engineer shall provide leadership and support for QMS performance in many facets of business operations: Design Control In this role, you will ensure that product development teams consistently apply strong critical thinking throughout the design and development process while maintaining deep expertise in Design Controls, Risk Management, Electrical Safety, and Usability Engineering.
You will be responsible for ensuring all design-related activities are properly executed, accurately documented, and fully compliant with internal procedures and global regulatory expectations. You will review Engineering Change Orders (ECOs) and proposed design modifications to confirm they reflect sound engineering practices and uphold device safety and effectiveness. You will also oversee the efficient progression of design changes, ensuring all documentation is complete, traceable, and compliant.
As an active participant in cross-functional design reviews, you will evaluate Design and Development Plans, Design Inputs and Outputs, verification and validation documentation, and design changes. Additionally, you will identify potential safety or performance risks and support appropriate risk management activities. Throughout the process, you will ensure that all design decisions are well justified, thoroughly documented, and aligned with regulatory and quality expectations.
Risk Management you will actively participate in risk management activities in alignment with ISO 14971, supporting hazard analyses, FMEAs, and the creation and maintenance of all related risk management documentation. You will ensure that risk control measures are properly implemented, thoroughly verified, and supported by objective evidence. You will apply structured, risk‑based decision‑making to ensure product safety and regulatory compliance, while also ensuring that all risk–benefit evaluations are clear, comprehensive, and aligned with global regulatory expectations.
Material Review Board The Sr. Quality Assurance Engineer shall 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 The Sr. Quality Assurance Engineer shall ensure that 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 In addition, the Senior Quality Assurance Engineer will support key Quality Management System (QMS) administration activities related to design and development. This includes conducting internal quality audits to verify compliance with internal procedures and global regulatory expectations, as well as leading or supporting Corrective and Preventive Actions (CAPA), including verifying effectiveness and ensuring all remediation activities are properly documented.
The role will manage Process Change Control for design‑related processes, ensuring changes are appropriately evaluated, documented, reviewed, and approved. The Senior QA Engineer will also support external audits and inspections by providing documentation, explaining processes, and representing relevant quality activities. Further responsibilities include assisting functional teams in understanding their quality obligations and maintaining alignment with the Spacelabs Quality Policy, as well as maintaining and improving QMS procedures, work instructions, and templates to ensure practices remain risk‑based, efficient, and compliant.
Responsibilities 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, systemic responsibilities, and customer requirements, as defined by Executive Management in the Spacelabs Quality Policy. As part of maintenance of the Spacelabs Quality Management System, Senior Quality Assurance Engineers shall partake in some or all of the following responsibilities: Ensure high quality of products and services, by implementing and maintaining the Quality Management System.
Ensure that QMS activities are risk-based. Perform, report, and drive remediation from Internal Quality Audits and participate in third party audit and inspection activities (MDR, MDSAP, etc.). Routinely pursue more efficient and effective operations (continual improvement). Support the development teams of all business areas, working within the project teams on new or sustaining product development projects.
Support the maintenance of the Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files. Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH, and Global regulatory requirements applicable to Spacelabs’ products. Provide Quality System guidance to his or her product design teams. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records.
Collaborate with engineering to determine and execute engineering design and development planning in support of regulatory submissions.</sp