OverviewThis 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.
QualificationsAn 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.
Key WordsISO 9001
ISO 17025
Supplier Quality
CAPA
Lead Auditor
Risk Management
Change Management
Continuous Improvement
Lean Six Sigma
SAP
