Validation-Focused Quality Engineer II

bdx; Cockeysville (MD); On-site; USD 76,000 - 121,000; Full time

Job summary

Waters seeks a Quality Engineer II, Validation to support and maintain Quality Systems in a regulated, high-volume environment. You will lead validation activities, monitor quality indicators, and drive CAPAs with cross-functional teams.

The role emphasizes CTQ risk assessments, data analysis, and continuous improvement to ensure product quality and regulatory compliance at Waters' Media plants and IDAST. On-site in Hunt Valley, MD.

Qualifications

• Bachelor’s degree in Biological Sciences, Chemistry, or related field.
• 2 years of Quality, Scientific Operations, or Engineering experience.

Responsibilities

• Develop, implement, and maintain Quality System procedures, SOPs, and quality policies.
• Lead validation activities including change validations and qualifications for Media plants and IDAST.
• Monitor trends and analyze quality indicators for materials, products, and components.
• Assess CTQ parameters and perform risk assessments to support product quality and process predictability.
• Apply statistical tools to identify root causes and implement corrective actions.
• Initiate and support CAPAs and lead investigations when required.
• Support process control initiatives to ensure consistent manufacturing practices.
• Identify and pursue continuous improvement opportunities for quality and efficiency.
• Manage day-to-day QM Engineering activities for assigned products.
• Collaborate with manufacturing and engineering for product launches and quality initiatives.
• Ensure Quality Systems are applied to new and existing product lines.
• Maintain FDA/ISO regulatory compliance across operations.

Skills

FDA 21 CFR 820

ISO 13485

Six Sigma

Statistical analysis

CAPA & root cause

Documentation writing

Education

Bachelor’s degree in Biological Sciences or Chemistry

Job description

Waters seeks a Quality Engineer II, Validation to support and maintain Quality Systems in a regulated, high-volume environment. You will lead validation activities, monitor quality indicators, and drive CAPAs with cross-functional teams.

The role emphasizes CTQ risk assessments, data analysis, and continuous improvement to ensure product quality and regulatory compliance at Waters' Media plants and IDAST. On-site in Hunt Valley, MD.