Senior Quality Engineer Hardware
Senior Quality Engineer Hardware
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$ 101000 - 140000
1 Vacancy
Job Description
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 IDNs 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 design control activities risk management activities and verification/validation activities ensuring products meet quality standards and regulatory 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 Quality Engineering tools techniques and methodologies to product development according to the companys needs and applicable regulations.
What youll do:
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.
What Were Looking For:
- Bachelors Degree in the engineering discipline or equivalent
- CQE RAC RAB ASQ or other quality and 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 IECCFR 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
- 50% - 70% Employer paid Health Dental & Vision for dependents (depending on plan selection)
- 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
$101000 - $140000 USD
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Required Experience:
Senior IC
Employment Type
Full Time
