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.

Company Description

Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.

Key Words

ISO 9001 ISO 17025 Supplier Quality CAPA Lead Auditor Risk Management Change Management Continuous Improvement Lean Six Sigma SAP