Supplier Quality Engineer

Hybrid Details: 3 days onsite/week
Duration: 8 months to start

Job Summary

A growing Supplier Quality team is looking for a Supplier Quality Engineer to help ensure the quality, compliance, and performance of the company's global supplier base. You'll join a collaborative, cross-functional team of three responsible for supplier qualification, risk mitigation, and quality performance - driving supplier accountability, supporting root cause investigations, and ensuring the supplier network meets regulatory and quality standards. The role combines engineering expertise with auditing skills, working directly with suppliers to resolve quality issues, implement corrective actions, and reduce risk.

Responsibilities

• Support supplier development programs, identifying capability gaps and building continuous improvement plans with key and critical suppliers, in partnership with Sourcing.
• Evaluate and manage Supplier Change Notifications (SCNs), coordinating cross-functional review of the potential quality and compliance impact of supplier changes.
• Conduct technical evaluations and qualifications for new and existing suppliers, reviewing manufacturing processes and compliance with engineering and quality requirements.
• Initiate and manage Supplier Corrective Action Requests (SCARs), driving root cause analysis, corrective action, and follow-up audits; prioritize by risk and partner with Procurement on supplier performance.
• Manage the Non-Conformance Material Report (NCMR) process, investigating root causes with suppliers and leading efforts to reduce repeat non-conformances.
• Develop and maintain supplier scorecards tracking quality, delivery, cost, and service, and collaborate with suppliers on improvement.
• Maintain the Approved Supplier List, qualifying and requalifying suppliers based on performance and audit results.
• Plan and conduct on-site and remote supplier audits of quality management systems and production processes, producing risk assessments and improvement recommendations.
• Perform supplier risk assessments and develop mitigation strategies for high-risk suppliers.
• Partner with suppliers on continuous improvement using root cause analysis and engineering methods; support validation of supplier processes and products, including first article inspections and process capability studies.
• Act as liaison between Quality, Procurement, Engineering, and Regulatory to align supplier strategy and decisions, ensuring adherence to FDA, GMP, and other applicable regulations.

Qualifications

• Bachelor's degree in Engineering, Quality, or a related technical field.
• 7+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance.
• Supplier QMS and process auditing experience (ISO 9001).
• Strong root cause analysis and corrective action (CAPA) skills.
• Proficiency conducting risk assessments and quality audits.
• Experience with eQMS systems or digital audit tools.
• Familiarity with regulatory standards such as FDA and GMP.
• Excellent communication, negotiation, and interpersonal skills.
• Willingness to travel for supplier audits and evaluations.

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