Supplier Quality Engineer

Position Overview

As a Supplier Quality Engineer at Ceribell, you will play a critical role in maintaining and improving the quality of our products by working closely with our suppliers. You will be responsible for assessing supplier capabilities, conducting audits, and implementing quality improvement initiatives to enhance the overall performance of our supply chain. This role is vital in ensuring that our products meet or exceed customer expectations.

What You’ll Do

• Evaluate potential and existing suppliers to ensure they meet our quality and performance standards. 
• Conduct supplier risk assessments and provide recommendations for supplier selection.
• Perform regular on-site and remote audits of supplier facilities to assess quality control processes, manufacturing practices, and compliance with industry standards and regulations.
• Collaborate with suppliers to identify areas for quality improvement, develop action plans, and monitor progress to enhance product quality and consistency.
• 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.
• Build strong relationships with suppliers to promote open communication and foster a collaborative environment for problem-solving and quality improvement.
• Maintain accurate records of supplier evaluations, audits, and quality-related communications. 
• Ensure compliance with all relevant documentation requirements.
• Stay up-to-date with industry regulations and standards related to supplier quality.
• Ensure that suppliers comply with all applicable requirements.
• Drive continuous improvement initiatives within the supply chain by identifying opportunities for cost savings, efficiency improvements, and quality enhancements.
• Collaborate with cross-functional teams, including R&D, manufacturing and procurement to ensure seamless integration of supplier quality into the product development process.

What You’ll Need

• Bachelor's degree in engineering, quality management or related discipline, preferred 
• 5+ years of experience in supplier quality engineering or a related roles 
• Strong understanding of regulatory requirements and quality standards relevant to medical devices ( ISO 13485, FDA QSR) 
• Experience with supplier auditing and assessment processes.
• Excellent problem-solving and analytical skills.
• Effective communication and interpersonal skills.
• Ability to work independently and collaboratively in a cross-functional team.
• Knowledge of regulatory requirements and quality standards relevant to the industry.
• Strong project management skills.