Ceribell, Inc
Senior Quality Engineer - Hardware Sunnyvale
Ceribell, Inc, Raleigh, North Carolina, United States
Position Overview
The Senior Quality Engineer ensures product quality and regulatory compliance throughout the product lifecycle. Supports design control activities, risk management, and verification/validation to ensure products meet quality standards and regulatory requirements. Works closely with Operations, R&D, and Suppliers on new product activities, supports production and continuous quality improvement, conducts audits, and supports investigations related to quality issues. Applies Quality Engineering tools and methodologies to product development according to the company’s needs and applicable regulations. What you\'ll do
Design Controls & Product Development Represent Quality Engineering in all design controls and product development related aspects. Lead and support design control activities, including compliance with ISO 13485 and 21 CFR 820, and implementation of 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 to development projects in a dynamic way. Drive the definition of design verification and validation test requirements to ensure objective evidence supports acceptance criteria, with concise conclusions and statistical validity. Support New Product Introduction (NPI) and change management processes with quality oversight. 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 leading the Materials Review Board and reviewing/approving nonconforming material. Work with Operations to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.). Establish process control and manufacturing metrics with manufacturing and quality functions and report regularly. Support investigation and resolution of failures in the field with Manufacturing, R&D, and Quality. Review engineering and manufacturing specifications to ensure compliance with customer requirements and industry standards. Interface with suppliers for new processes, quality issues, and process improvements on 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 KPIs to track supplier performance; analyze data to identify trends and corrective actions. Investigate and resolve supplier-related quality issues using root cause analysis and preventive measures for non-conformances (NCRs). Manage the Approved Supplier List (ASL) and maintain records of supplier evaluations, audits, and quality communications. Collaborate with cross-functional teams 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, manufacturing practices, and regulatory compliance. Quality Systems & Compliance Conduct internal and external audits to ensure compliance with ISO 13485 or other relevant standards. Maintain quality systems in accordance with ISO 13485, QMSR, and applicable regulatory requirements. Perform gap assessments as assigned for standards and regulations. Investigate quality issues, identify root causes, and implement corrective and preventive actions (CAPAs). 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. What We\'re Looking For
Bachelor\'s Degree in the engineering discipline, or equivalent CQE, RAC, RAB, ASQ or other quality/regulatory certificates are beneficial. 3-5 years of quality experience in a medical device company, including design controls, product/process validation, and technical problem solving. Strong knowledge of ISO 13485, ISO 14971, IEC62366, IEC62304, 21 CFR 820, and quality concepts (e.g. NC/CAPA). Proficiency in statistical analysis, trend analysis, and methodologies such as FMEA, root cause analysis, and risk assessment tools. Experience with tools such as Jira, Minitab, DOORS, or equivalent platforms used for traceability and risk analysis. Ability to lead quality initiatives, troubleshoot complex issues, and drive continuous improvement with a proactive and solutions-oriented mindset. Effective communicator with strong interpersonal skills, able to collaborate across all levels of the organization, suppliers, and customers. Strong team player with a commitment to product excellence and quality. Ability to maintain accurate, compliant documentation within a regulated environment. Willingness to travel internationally (up to 20%). In addition to your base compensation, Ceribell offers the following: Annual Bonus + Equity Opportunity 100% Employer paid Health Benefits for Employees 100% paid Life and Long-Term Disability Insurance 401(k) with a generous company match Employee Stock Purchase Plan (ESPP) with a discount Monthly cell phone stipend Flexible paid time off 11 Paid Holidays + 5 Company Wellness Days Excellent parental leave policy Fantastic culture with tremendous career advancement opportunities Joining a mission-minded organization! Compensation Range $101,000 - $140,000 USD Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is voluntary and confidential. This information will not be used in hiring decisions. Equality statement: Ceribell, Inc does not discriminate on the basis of protected status. If you belong to protected veteran categories, there are options to indicate that as part of the process. This information is collected in accordance with VEVRAA and related laws.
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The Senior Quality Engineer ensures product quality and regulatory compliance throughout the product lifecycle. Supports design control activities, risk management, and verification/validation to ensure products meet quality standards and regulatory requirements. Works closely with Operations, R&D, and Suppliers on new product activities, supports production and continuous quality improvement, conducts audits, and supports investigations related to quality issues. Applies Quality Engineering tools and methodologies to product development according to the company’s needs and applicable regulations. What you\'ll do
Design Controls & Product Development Represent Quality Engineering in all design controls and product development related aspects. Lead and support design control activities, including compliance with ISO 13485 and 21 CFR 820, and implementation of 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 to development projects in a dynamic way. Drive the definition of design verification and validation test requirements to ensure objective evidence supports acceptance criteria, with concise conclusions and statistical validity. Support New Product Introduction (NPI) and change management processes with quality oversight. 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 leading the Materials Review Board and reviewing/approving nonconforming material. Work with Operations to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.). Establish process control and manufacturing metrics with manufacturing and quality functions and report regularly. Support investigation and resolution of failures in the field with Manufacturing, R&D, and Quality. Review engineering and manufacturing specifications to ensure compliance with customer requirements and industry standards. Interface with suppliers for new processes, quality issues, and process improvements on 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 KPIs to track supplier performance; analyze data to identify trends and corrective actions. Investigate and resolve supplier-related quality issues using root cause analysis and preventive measures for non-conformances (NCRs). Manage the Approved Supplier List (ASL) and maintain records of supplier evaluations, audits, and quality communications. Collaborate with cross-functional teams 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, manufacturing practices, and regulatory compliance. Quality Systems & Compliance Conduct internal and external audits to ensure compliance with ISO 13485 or other relevant standards. Maintain quality systems in accordance with ISO 13485, QMSR, and applicable regulatory requirements. Perform gap assessments as assigned for standards and regulations. Investigate quality issues, identify root causes, and implement corrective and preventive actions (CAPAs). 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. What We\'re Looking For
Bachelor\'s Degree in the engineering discipline, or equivalent CQE, RAC, RAB, ASQ or other quality/regulatory certificates are beneficial. 3-5 years of quality experience in a medical device company, including design controls, product/process validation, and technical problem solving. Strong knowledge of ISO 13485, ISO 14971, IEC62366, IEC62304, 21 CFR 820, and quality concepts (e.g. NC/CAPA). Proficiency in statistical analysis, trend analysis, and methodologies such as FMEA, root cause analysis, and risk assessment tools. Experience with tools such as Jira, Minitab, DOORS, or equivalent platforms used for traceability and risk analysis. Ability to lead quality initiatives, troubleshoot complex issues, and drive continuous improvement with a proactive and solutions-oriented mindset. Effective communicator with strong interpersonal skills, able to collaborate across all levels of the organization, suppliers, and customers. Strong team player with a commitment to product excellence and quality. Ability to maintain accurate, compliant documentation within a regulated environment. Willingness to travel internationally (up to 20%). In addition to your base compensation, Ceribell offers the following: Annual Bonus + Equity Opportunity 100% Employer paid Health Benefits for Employees 100% paid Life and Long-Term Disability Insurance 401(k) with a generous company match Employee Stock Purchase Plan (ESPP) with a discount Monthly cell phone stipend Flexible paid time off 11 Paid Holidays + 5 Company Wellness Days Excellent parental leave policy Fantastic culture with tremendous career advancement opportunities Joining a mission-minded organization! Compensation Range $101,000 - $140,000 USD Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is voluntary and confidential. This information will not be used in hiring decisions. Equality statement: Ceribell, Inc does not discriminate on the basis of protected status. If you belong to protected veteran categories, there are options to indicate that as part of the process. This information is collected in accordance with VEVRAA and related laws.
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