Job Description
Overview
At Spacelabs Healthcare, we’re 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’re 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 & Product Development
- Mentor design teams on Design Controls, Risk Management, and Electrical Safety.
- Review Engineering Change Orders for sound engineering practices and compliance.
- Support technical documentation including Essential Requirements Checklists and Risk Management Files.
- Collaborate with engineering on regulatory submissions and design planning.
Manufacturing & Process Improvement
- Oversee manufacturing processes, work instructions, and inspection protocols.
- Approve Device History Records to ensure compliance with Device Master Record requirements.
- Conduct 7S-based floor walkthroughs to drive operational improvements.
Post-Market Surveillance & Service
- Monitor product performance and service documentation.
- Escalate and address defects, assess trends, and identify improvement opportunities.
Quality System Administration
- Lead internal audits, CAPA, process change control, and supplier quality activities.
- Maintain compliance with ISO, MDR/MDD, MDSAP, and other global standards.
- Support regulatory filings including (k), CE Mark, and IDE submissions.
Material Review Board (MRB)
- Facilitate efficient processing of Nonconforming Material Reports and Rework Orders.
- Track and report MRB metrics to minimize backlog and improve throughput.
Qualifications
- Bachelor’s degree in Engineering, Quality, or related field (e.g., Biomedical, Electrical, Software).
- 7+ years in Quality or Engineering roles.
- 5+ years in medical device regulatory and QMS environments.
- Experience with SaMD or embedded software in medical devices.
- Strong knowledge of technical documentation and change control.
- Proficient in statistical analysis and risk-based QMS activities.
- Excellent communication skills and a proactive, organized approach.