ABOUT CERIBELL

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN’s across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!
Position Overview:
The Senior Quality Engineer ensures product quality and compliance with regulations throughout the product lifecycle. Support design control activities, risk management activities, and verification/validation activities, ensuring products meet quality standards and regulatory requirements. Work closely with Operations, R&D, and Suppliers (as applicable) on new product activities and support production and continuous quality improvement, conduct audits, and support investigations related to quality issues. Applies Quality Engineering tools, techniques, and methodologies to product development according to the company’s needs and applicable regulations.

Design Controls & Product Development

• Represent Quality Engineering in all Design Controls and Product Development related aspects.
• Lead and support design control activities, including ensuring compliance with ISO 13485 and 21 CFR 820, and implementing ISO 14971 risk management processes.
• Collaborate with cross-functional teams to manage design requirements, risk assessments, and design history file documentation.
• Review Design History File (DHF) documentation including design inputs, outputs, verification/validation protocols and reports, risk management files, and design transfer records for completeness.
• Ensure traceability between user needs, design inputs, design outputs, and verification/validation activities.
• Apply Quality Engineering principles and tools in a dynamic way to development projects.
• Drive the definition of design verification and validation test requirements that will ensure appropriate objective evidence will be available to support acceptance criteria are met by providing concise conclusions with statistical validity and graphical support.
• Support New Product Introduction (NPI) and change management processes with quality oversight.

Risk Management

• Risk Management: Develop, maintain, and contribute to risk management documentation and processes throughout the product life cycle, from conception to decommissioning.

Manufacturing & Operational Quality

• Support manufacturing quality – including but not limited to: Lead the Materials Review Board, and review/approve nonconforming material.
• Work closely with Operations to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.).
• Work with manufacturing and quality function to establish process control and manufacturing metrics and report regularly.
• Support Manufacturing, R&D and Quality function in failure investigation and issue resolution for failures in the field.
• Review engineering and manufacturing specifications to ensure compliance with customer requirements and industry standards.

Supplier Quality

• Interface with Suppliers for new processes, quality issues and process improvements for assigned projects.
• Supplier Quality: Support supplier selection, evaluation, and auditing to ensure adherence to quality standards and agreements.
• Manage supplier quality performance and conduct supplier assessments.
• Establish and monitor key performance indicators (KPIs) to track supplier performance. Analyze data to identify trends and areas requiring corrective actions.
• Investigate and resolve supplier-related quality issues by employing root cause analysis methodologies and implementing preventive measures to address non-conformance (NCRs).
• Responsible for managing the Approved Supplier List (ASL), maintaining accurate records of supplier evaluations, audits, and quality-related communications.
• Collaborate with cross-functional teams, including R&D, manufacturing and procurement to ensure seamless integration of supplier quality into the product development process.
• Perform regular on-site and remote audits of supplier facilities to assess quality control processes, manufacturing practices, and compliance with industry standards and regulations.

Quality Systems & Compliance

• Conduct internal and external audits to ensure compliance with ISO 13485, or other relevant standards.
• Support and maintain quality systems in accordance with ISO 13485, QMSR and applicable regulatory requirements.
• Perform Standard/Regulation gap assessments as assigned.

CAPA & Continuous Improvement

• Investigate quality issues, identify root causes, and implement corrective and preventive actions.
• Lead CAPA investigations related to design issues and ensure timely closure of quality events.
• Promote and lead continuous improvement activities using Lean, Six Sigma, or other quality methodologies.

Data & Performance Analysis

• Analyze quality data and generate reports to identify trends and areas for improvement.
• Monitor and report on quality performance through KPIs, audits, and inspections.

Cross-Functional Collaboration

• Collaborate with cross-functional teams to ensure product quality from design to delivery.
• Partner with R&D, Regulatory Affairs, and Manufacturing to support product launches and design transfers.
• Participate in Change Control processes for design and documentation updates.