Supplier Quality Engineer in Carlsbad

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Job Description

Position Overview:

We are seeking an experienced and driven Supplier Quality Engineer (SQE) to lead supplier quality initiatives, manage supplier performance, and ensure compliance with internal and external quality standards. This role is critical in building a robust supply base that supports product excellence and regulatory compliance.

Responsibilities:

• Evaluate and qualify new suppliers through audits, assessments, and technical reviews.
• Monitor supplier performance using KPIs such as PPM, on-time delivery, and quality metrics.
• Lead supplier-related investigations for nonconforming materials and components, including root cause analysis and corrective actions.
• Conduct supplier audits (remote and on-site) and support supplier development programs.
• Manage Supplier Corrective Action Requests (SCARs) and ensure timely and effective resolution.
• Collaborate with Procurement, Engineering, and Manufacturing to address supplier issues and improve quality outcomes.
• Develop and maintain supplier quality agreements and ensure compliance with applicable standards (e.g., ISO 13485, FDA QSR, EU MDR, and risk management per ISO 14971).
• Support incoming inspection processes and define acceptance criteria for critical components.
• Conduct periodic supplier audits and participate in supplier development initiatives.
• Maintain documentation and records in accordance with regulatory and internal requirements.
• Other duties as assigned.

Qualification:

• Bachelor’s degree in engineering, Quality, or related field.
• 5+ years of experience in supplier quality or manufacturing quality in a regulated industry.
• Strong knowledge of quality systems and standards (e.g., ISO 13485, FDA QSR, EU MDR, and risk management per ISO 14971).
• Experience with root cause analysis tools (5 Whys, Fishbone, 8D) and CAPA processes.
• Familiarity with inspection methods, metrology, and statistical quality control.
• Excellent communication, negotiation, and problem-solving skills.
• Certified Quality Engineer (CQE), Lead Auditor certification, or Six Sigma certification.
• Familiarity with global supply chains and international supplier regulations

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