Sr. Quality Engineer

Overview

This role supports the Material Sciences Quality Management System (QMS), product quality, and supplier quality programs at the New Castle, Delaware manufacturing facility. The position is highly cross-functional and focuses on driving quality improvements, managing supplier performance, ensuring ISO 9001 and 17025 compliance, leading investigations, and supporting audits.

 

Responsibilities

 

• Continuously support and improve the ISO 9001 and 17025 Quality Management System (QMS), including quality metrics, nonconformance processes, complaint handling, and audit readiness.

 

• Lead product and supplier quality investigations, including root cause analysis, CAPA execution, effectiveness verification, and resolution of nonconformances.

 

• Drive supplier quality management, including supplier qualification, performance monitoring, SCARs, quality agreements, and supplier change notification (PCN) activities.

 

• Conduct and support internal, external, and supplier audits, ensuring compliance and timely closure of findings and corrective actions.

 

• Facilitate MRB and quality review meetings, analyze trends and KPIs, and communicate quality performance to leadership and cross-functional teams.

 

• Lead continuous improvement and product quality initiatives across manufacturing, engineering, procurement, and suppliers to enhance compliance, reliability, and customer satisfaction.

 

Qualifications

 

An experienced quality professional who can work independently, influence cross-functional teams, perform audits, drive systemic improvements, and ensure suppliers consistently meet quality and business requirements. Experience in instrument manufacturing is highly desirable. 

 

• Bachelor's degree in Engineering, Science, or related technical field.

 

• Minimum 10 years of Quality Assurance or related experience.

 

• Minimum 3-5 years in Supplier Quality, Supply Chain, or related disciplines.

 

• Strong understanding of ISO 9001 Quality Management Systems.

 

• Experience with ISO 17025 requirements.

 

• Certified ISO 9001 Lead Auditor preferred/required.

 

• Proven experience managing CAPA systems and root cause investigations.