Quality Engineer II - Regulated Life Sciences

BD; Sparks (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

Waters Corporation is seeking a Quality Engineering II to support the Quality Management System (QMS) in a life sciences manufacturing setting, focusing on product quality, processes, and patient safety. The role emphasizes CAPA, risk assessments, and cross-functional collaboration with R&D, Manufacturing, and Regulatory Affairs.

You will ensure cGMP alignment, participate in audits, and mentor junior staff, while working with a team that values accuracy and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3–5 years of experience in a Quality Engineering role within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology).
• Strong understanding of Quality Management Systems (QMS) principles and practical application.
• Demonstrated experience with root cause analysis methodologies (e.g., 5 Whys, Fishbone) and CAPA implementation.
• Familiarity with statistical process control (SPC) and other quality tools.
• Excellent written and verbal communication skills; ability to present technical information clearly.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 regulations is highly preferred.
• ASQ certification (e.g., CQE) is a plus.

Responsibilities

• Lead and participate in investigations of non-conformances, deviations, and out-of-specification results, identifying root causes and implementing CAPA.
• Develop, review, and approve quality documentation including procedures, specifications, and test methods.
• Support validation activities for equipment, processes, and software, including protocol and report generation and execution oversight.
• Perform risk assessments and develop mitigation strategies to ensure product quality and patient safety.
• Contribute to internal and external audit programs, including preparation, execution, and follow-up.

Skills

CAPA

Root Cause Analysis

QMS

SPC

Regulatory Knowledge

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Microsoft Office

Job description

Waters Corporation is seeking a Quality Engineering II to support the Quality Management System (QMS) in a life sciences manufacturing setting, focusing on product quality, processes, and patient safety. The role emphasizes CAPA, risk assessments, and cross-functional collaboration with R&D, Manufacturing, and Regulatory Affairs.

You will ensure cGMP alignment, participate in audits, and mentor junior staff, while working with a team that values accuracy and continuous improvement.