Senior Quality Assurance Engineer (medical devices)

At Spacelabs Healthcare, we are committed to transforming healthcare through continuous innovation. Our scalable solutions deliver critical patient data across local and remote systems, empowering better decisions, improving efficiency, and enhancing patient safety.

Role Overview: We are seeking a Senior Quality Assurance Engineer to lead and support Quality Management System (QMS) performance across design, manufacturing, service, and compliance functions. This role is pivotal in ensuring our medical devices are safe, effective, and compliant with global standards.

Responsibilities:

• 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 critical thinking. 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. He or she shall ensure that the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance.
• The Sr. Quality Assurance Engineer shall 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. The Sr. Quality Assurance Engineer shall ensure that product Design Change activities move ahead in a timely and effective manner.
• Manufacturing: The Sr. Quality Assurance Engineer shall 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: 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 backlog.
• 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: Sr. Quality Assurance Engineers are 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.
• 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.
• Review Engineering Change Requests and Engineering Change Orders to identify critical components, defects in drawings/schematics, effective and adequate design documentation, product safety, and Quality System compliance.
• Assist with the creation, maintenance, and performance of QMS change management tools: Corrective Action Reports (CARs), Preventive Action Reports (PARs), and Process Change Orders (PCOs).
• Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements.
• Shall review and approve Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements.
• Perform Manufacturing floor walkthroughs based on 7S criteria to support improvements and collaboration.
• Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders.
• Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP.
• Assist in the preparation and submittal of registration applications. May assist in the preparation of IDE, 510(k), CE Mark, and other similar regulatory filings.
• Shall participate in cross-functional design teams to review all Design and Development Plans, Design Inputs, Design Outputs, V&V documents, and Design Changes including Defect Reports. Senior Quality Assurance Engineers shall recognize potential impacts to health or device efficacy (Safety Issues), support criticality assessment needed to ensure the application of reasonable and required Risk Management, Verification and Validation, and adequate record-keeping practices.

Requirements:

• Bachelor's degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical).
• Attend office three times per week in Edinburgh.
• 7+ years related Quality / Engineering work experience.
• 5+ years of experience with medical device regulatory and quality and Quality Management Systems.
• Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation.
• Experience with statistical analysis.
• Knowledge of Software as a Medical Device (SaMD) or Software within a device required.
• Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards.
• Proven ability to communicate effectively with staff at all levels of the organization.
• Self-motivated and organized.