VeloMini Edinburgh, Scotland, United Kingdom
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
Provide Quality System Design Control mentoring to ensure product design teams use critical thinking. Ensure all Design Control, Risk Management, Electrical Safety, and associated processes, policies, procedures, and records are correctly performed, documented, and timely. Review Engineering Change Orders and proposed changes to ensure sound engineering practice, effective 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 product manufacturing processes, facilitating adequate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling.
Material Review Board
Facilitate processing of Nonconforming Material Reports and Rework Orders. Capture, monitor, and report process performance metrics to ensure timely MRB throughput and minimized quarantine backlog.
Installation and Service
Ensure post‑market activities maintain intended device performance. Document service and support activities, escalated defect handling, and assess performance trends to 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. Follow guidance of RA/QA Management and help other functions understand and fulfill obligations to meet quality objectives. Participate in cross‑functional design teams, support maintenance of Essential Requirements Checklists, Technical Documentation Files, and ensure compliance to regulatory standards.
Key Responsibilities List
* Ensure high quality of products and services, by implementing and maintaining the Quality Management System.
* Ensure 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 project teams on new or sustaining product development projects.
* Support maintenance of Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files.
* Assist with 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 product design teams.
* 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 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.
* Review and approve Device History Record (DHR) deliverables to ensure compliance 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 preparation and submittal of registration applications. May assist in preparation of IDE, 510(k), CE Mark, and other similar regulatory filings.
* Unite company core values of Integrity, Innovation, Accountability, and Teamwork.
* Demonstrate behavior consistent with the company Code of Ethics and Conduct.
* Report quality problems or defects to management to implement corrective action and avoid recurrence.
* Duty may be modified or assigned at any time to meet business needs.
Qualifications
* Bachelor’s degree in Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical).
* 7+ years related Quality / Engineering work experience.
* 5+ years 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.
Career Information
* Seniority level: Mid‑Senior level
* Employment type: Full‑time
* Job function: Information Technology
* Industries: IT System Testing and Evaluation
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