Senior Quality Engineer - ISO 9001 & CAPA Leader

tacareers-waters; New Castle (DE); On-site; USD 110,000 - 160,000; Full time

Job summary

Waters Corporation in New Castle, Delaware seeks a senior quality professional to support the Material Sciences QMS, product quality, and nonconforming product processes at the New Castle facility. Responsibilities include leading investigations, audits, CAPA, and driving Continuous Improvement; collaborate across R&D, Engineering, Operations, and Regulatory to harmonize activities across Waters sites.

The role emphasizes hands-on leadership in a fast-paced environment with strong ISO 9001/17025

Qualifications

• Bachelor’s degree in engineering, business, science, or technical field.
• At least 10 years in Quality Assurance or related field.
• Experience with ISO 9001 and 17025; Lead Auditor certification preferred.
• Proven CAPA and problem-solving skills.
• Experience with SAP or Oracle is a plus.

Responsibilities

• Ensure compliance to ISO 9001 QMS Processes.
• Develop and maintain the QMS.
• Identify areas of improvement within manufacturing and QMS.
• Maintain QMS metrics.
• Support Non-Conformance & Complaint systems.
• Compile quality data and support audits and root cause analysis.

Skills

Quality Assurance

ISO 9001

CAPA process

Lead Auditor

17025 experience

Project management

Six Sigma

SAP or Oracle

Analytical thinking

Independent collaboration

Education

Bachelor's degree (Engineering, Business, Science)

Tools

SAP

Oracle

Job description

Waters Corporation in New Castle, Delaware seeks a senior quality professional to support the Material Sciences QMS, product quality, and nonconforming product processes at the New Castle facility. Responsibilities include leading investigations, audits, CAPA, and driving Continuous Improvement; collaborate across R&D, Engineering, Operations, and Regulatory to harmonize activities across Waters sites.

The role emphasizes hands-on leadership in a fast-paced environment with strong ISO 9001/17025