Liquid Media Quality Engineer II - QA & Compliance

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

Job summary

Waters is seeking a Quality Engineer to develop and maintain Quality System procedures and SOPs in a regulated environment. You will lead validation activities for media plants and IDAST, monitor quality indicators, and perform risk assessments to support product quality and process predictability.

Responsibilities include CAPA leadership, data analysis, and collaboration with manufacturing and engineering to drive continuous improvement and successful product launches in a demanding facility.

Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, or other related science field.
• 2 years experience in Quality or Engineering.
• Experience in technical writing and executing validations is preferred.

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, trend, and analyze quality indicators for materials, products, and components.
• Assess CTQ parameters and perform risk assessments to support quality and process decisions.
• Apply statistical tools to identify root causes, resolve issues, and implement corrective actions.
• Initiate and support CAPAs, including leading investigations when required.
• Support process control initiatives and promote consistent manufacturing practices.
• Identify and recommend continuous improvement opportunities to enhance quality and efficiency.
• Manage day-to-day QM Engineering activities for assigned products and projects.
• Partner with manufacturing, engineering, and cross-functional teams for product launches and quality initiatives.
• Ensure consistent implementation of Quality Systems for new and existing product lines.
• Maintain compliance with FDA regulations, ISO standards, and other requirements.
• Support quality-related activities including change controls, PQNs, post-market activities, IVDR compliance, and customer complaints.
• Utilize enterprise systems and quality tools to drive compliance and documentation.

Skills

Quality Systems

SOPs

Validation

CAPA

GxP

FDA 21 CFR 820

ISO 13485

Risk management

Education

Bachelor's degree in Biological Sciences or related

Tools

Statistical software

Job description

Waters is seeking a Quality Engineer to develop and maintain Quality System procedures and SOPs in a regulated environment. You will lead validation activities for media plants and IDAST, monitor quality indicators, and perform risk assessments to support product quality and process predictability.

Responsibilities include CAPA leadership, data analysis, and collaboration with manufacturing and engineering to drive continuous improvement and successful product launches in a demanding facility.