At Spacelabs Healthcare, we’re committed to transforming healthcare through continuous innovation. Our scalable solutions deliver critical patient data across local and remote systems, enabling clinicians to act with confidence and improving outcomes for patients worldwide.
We are seeking a Senior Quality Assurance Engineer who will play a pivotal role in ensuring our medical devices are safe, effective, and compliant. This individual will lead Design Controls, Risk Management, and Quality Management System (QMS) governance throughout the product lifecycle—primarily focusing on design and pre‑market activities. Acting as a trusted partner to R&D and Regulatory Affairs, you will help drive informed decision‑making that safeguards patients while enabling compliant innovation.
Key Responsibilities
Design & Development Quality Leadership
- Champion critical thinking across product development teams throughout all stages of design and development.
- Serve as a subject‑matter expert in Design Controls, Risk Management, Electrical Safety, and Usability Engineering.
- Ensure all design activities are properly executed, accurately documented, and compliant with internal procedures and global regulatory requirements.
- Review Engineering Change Orders (ECOs) and design changes to confirm sound engineering practice and maintained device safety and effectiveness.
- Oversee efficient progression of design changes with complete, traceable, and compliant documentation.
- Participate in cross‑functional design reviews, assessing design plans, inputs, outputs, V&V evidence, and change records.
- Identify potential safety or performance concerns and support appropriate risk management activities.
- Ensure design decisions are fully justified, documented, and aligned with regulatory expectations.
Risk Management
- Contribute to risk management activities in accordance with ISO 14971.
- Support hazard analyses, FMEAs, and related risk management documentation.
- Ensure risk control measures are implemented, verified, and supported by objective evidence.
- Provide structured, risk‑based decision‑making to support product safety and compliance.
- Ensure risk–benefit evaluations are complete, clear, and aligned with global regulatory expectations.
Material Review Board (Design‑Related)
While the role does not oversee manufacturing or service activities, you will:
- Participate in design‑related reviews of nonconforming materials and investigations where they impact design decisions, safety, or documentation.
- Communicate trends or recurring issues to design teams.
- Support corrective actions or design improvements based on nonconformance insights.
QMS Administration
- Conduct internal quality audits to verify compliance with procedures and regulatory expectations.
- Lead or support CAPA activities, ensuring effective verification and complete documentation.
- Manage process change control for design‑related processes, ensuring proper evaluation, documentation, and approval.
- Support external audits/inspections by representing design‑related quality processes.
- Educate internal teams on quality obligations and alignment with the Spacelabs Quality Policy.
- Maintain and improve QMS procedures, work instructions, and templates.
Qualifications
- Bachelor’s degree in Quality, Engineering, or related fields (e.g., Computer/Software, Biomedical, Mechanical, Electrical).
- 7+ years of relevant Quality or Engineering experience.
- 5+ years working with medical device regulatory requirements, quality standards, and QMS.
- Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Files, Design History Files, MVPs, and Change Control documentation.
- Experience with statistical analysis.
- Knowledge of Software as a Medical Device (SaMD) or software within medical devices.
- Experience collaborating with teams under design controls during new product development.
- Strong communication skills across all levels of an organization.
- Highly self‑motivated, organized, and proactive.