Quality Validation Engineer II

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

Job summary

Waters Corporation in Maryland is seeking a Quality Engineer II, Validation to support and maintain Quality Systems across media manufacturing. The role emphasizes validation writing and execution, and compliance with FDA and ISO standards while collaborating with manufacturing and engineering teams.

The position focuses on assessing CTQ, performing risk analyses, and driving CAPAs and continuous improvement to ensure product quality and process reliability.

Qualifications

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

Responsibilities

• Develop, implement, and maintain Quality System procedures, Standard Operating Procedures (SOPs), and quality policies.
• Lead and execute validation activities, including change validations and recurring process/equipment qualifications for Media plants and IDAST.
• Monitor, trend, and analyze quality indicators for purchased materials, manufactured products, and distributed components.
• Assess CTQ parameters and perform risk assessments to support product quality and decision-making.
• Apply statistical tools and data analysis to identify root causes and implement corrective actions.
• Initiate and support CAPAs, including investigations and corrective actions when required.
• Support process control initiatives and promote consistent manufacturing practices.
• Identify and recommend continuous improvement opportunities to enhance quality, efficiency, and compliance.
• Manage day-to-day QM Engineering activities for assigned products and projects.
• Partner with cross-functional teams to support product launches and quality initiatives.
• Ensure consistency of Quality Systems for new and existing product lines.
• Maintain compliance with FDA, ISO and other quality/regulatory requirements.

Skills

FDA 21 CFR 820

ISO 13485/14971

Statistical analysis

CAPA

Education

Bachelor's degree in Biological Sciences or related field

Job description

Waters Corporation in Maryland is seeking a Quality Engineer II, Validation to support and maintain Quality Systems across media manufacturing. The role emphasizes validation writing and execution, and compliance with FDA and ISO standards while collaborating with manufacturing and engineering teams.

The position focuses on assessing CTQ, performing risk analyses, and driving CAPAs and continuous improvement to ensure product quality and process reliability.