Quality Engineer

Overview

This position is responsible for the ongoing development, implementation and maintenance of the Quality Management System and Good Manufacturing Practice (cGMP) compliance to regulatory Systems/Standards (e.g. 21CFR 820) in addition to the generation and maintenance of the site quality strategy.

Responsibilities

As part of the team you will be responsible for

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• The assessment of compliance with ISO9001, ISO13485 and applicable Good Manufacturing Practice regulations within the company.
• Liaise with suppliers to resolve product quality issues.
• Supporting Chemistry Manufacturing Operations - Engineering Changes, Deviations.
• Handle Non-Conformances and Quarantine Material Dispositions.
• Provide QMS and Regulatory guidance support.
• Manufacturing documentation.
• Support New Product Introduction.
• Analyse and report data for Supplier Review.
• Prepare, conduct, report, and follow-up on internal & Supplier audits.
• Provide support to other support departments - audits, compliance, projects.
• Support Lean Initiatives and LDMS Boards.
• Support / Lead Projects and CAPA Investigation

Qualifications

Education

• BSc or equivalent academic qualifications.

Experience

• Previous manufacturing experience of working in an ISO9001, ISO13485 or cGMP environment.
• Desirable - SAP and Trackwise

Competencies

• Attention to detail
• Good interpersonal & communication skills
• Ability to work on own initiative
• Accountable
• Problem Solver

Travel (If Applicable)

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.