Quality Engineer II - Liquid Media

Quality Engineer II supporting liquid media manufacturing operations at Waters Corporation (formerly BD Biosciences). Develops quality procedures, executes validation activities, analyzes quality data, and partners with cross-functional teams to ensure compliance with FDA and ISO standards.

Responsibilities

• Develop and maintain Quality System procedures, SOPs, and policies
• Lead validation activities including change validations and equipment qualifications for media plants
• Monitor and analyze quality indicators for materials, products, and distributed components
• Initiate and support corrective and preventive actions with root cause analysis
• Partner with manufacturing and engineering teams on product launches and process improvements

Requirements

• Bachelor's degree in Biological Sciences, Chemistry, or related science field
• 2 years experience in Quality or Engineering roles
• Moderate knowledge of FDA 21 CFR 820 and ISO 13485/14971 standards
• Statistical analysis and process control skills (SPC, Six Sigma, root cause analysis)
• Ability to manage multiple tasks and execute change management plans
• Technical writing and process/test method validation experience preferred