Senior Quality Assurance & ISO 9001 Lead Auditor

Waters Corporation; Holloway Terrace (DE); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Waters Corporation in New Castle, Delaware, seeks an experienced Quality Engineer to support QMS processes, product quality, and nonconforming product handling at our manufacturing site. You will lead investigations into non-conformances, report quality metrics, and drive improvements across transfers to production and audits.

The role requires collaboration with R&D, Engineering, Operations, Regulatory and Purchasing, and hands-on problem solving with a bias for continuous improvement, ISO 9001

Qualifikationen

• Bachelor's degree in engineering, business, mathematics, science, or technical field.
• Minimum 10 years of experience in Quality Assurance or related field.
• Experience with ISO 9001, CAPA, audits, and non-conforming product handling.

Aufgaben

• Lead investigations into product non-conformances and root-cause analysis.
• Report quality system metrics and track CAPA effectiveness.
• Support QMS maintenance, audits, and supplier/product transfers to production.
• Collaborate with R&D, Engineering, Operations, and Regulatory to harmonize QA activities.
• Maintain familiarity with ISO 9001 and 17025 requirements.

Kenntnisse

Quality Assurance

CAPA process

ISO 9001

Auditing

Lean Six Sigma

SAP/Oracle

Ausbildung

Bachelor's degree in engineering or related field

Tools

SAP

Oracle

Jobbeschreibung

Waters Corporation in New Castle, Delaware, seeks an experienced Quality Engineer to support QMS processes, product quality, and nonconforming product handling at our manufacturing site. You will lead investigations into non-conformances, report quality metrics, and drive improvements across transfers to production and audits.

The role requires collaboration with R&D, Engineering, Operations, Regulatory and Purchasing, and hands-on problem solving with a bias for continuous improvement, ISO 9001