Quality Engineer

About the role

The Quality Engineer will drive the development, implementation, and maintenance of Waters' Quality Management System (QMS) and ensure cGMP compliance across manufacturing operations. You will work closely with internal teams and external suppliers to uphold regulatory standards and support new product introductions.

Key responsibilities

• Assess compliance with ISO 9001, ISO 13485, and applicable cGMP regulations.
• Liaise with suppliers to resolve product quality issues and conduct supplier audits.
• Support chemistry manufacturing operations, including engineering changes, deviations, and non‑conformance handling.
• Manage quarantine material dispositions and provide QMS/regulatory guidance.
• Prepare, conduct, report, and follow‑up on internal and supplier audits.
• Support manufacturing documentation, new product introduction, and data analysis for supplier reviews.
• Lead or support projects, CAPA investigations, Lean initiatives, and LDMS board activities.

Required profile

• BSc or equivalent academic qualification.
• Previous manufacturing experience in an ISO 9001, ISO 13485 or cGMP environment.
• Strong attention to detail, problem‑solving ability, and capacity to work independently.
• Good interpersonal and communication skills.

Required skills

• SAP
• Trackwise
• ISO 9001
• ISO 13485
• cGMP