Senior Quality Engineer - GMP, CAPA & Process Excellence

Becton Dickinson NA; Cockeysville (MD); On-site; USD 96,000 - 153,000; Full time

Job summary

Waters is seeking a Senior Quality Engineer to ensure compliance with Quality System, ISO, and FDA requirements by developing and implementing SOPs, quality policies, and process controls across plant operations. You will drive improvements, support audits, manage CAPAs, and lead product launches with cross-functional teams.

The role emphasizes data-driven decisions using SPC and root cause analysis, requires a bachelor’s degree in sciences and 3 years of quality engineering experience in a

Qualifications

• Bachelor's degree in sciences or other relevant technical field.
• 3 years' experience in Quality Engineering or other related field.
• Experience in a medical device, pharmaceutical manufacturing facility, or other relevant manufacturing field.
• Knowledge and Skills: Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience.

Responsibilities

• Monitor, analyze, and trend quality indicators for materials, as well as manufactured and distributed components and products, to drive product quality and performance improvements.
• Evaluate CTQ parameters and risk assessment variables to support informed decision-making, predictable product design, and efficient product flow.
• Serve as a key Quality Management (QM) Engineering resource, supporting both Media QM Engineering initiatives and day-to-day quality engineering activities for assigned products and operational areas.
• Partner with the Plant Senior Quality Manager to ensure consistent Quality Systems across new and existing product lines and enterprise systems.
• Support ISO, FDA, and internal quality requirements through audits, cross-functional collaboration, and CAPA coordination.
• Utilize root cause analysis methodologies and quality tools to identify issues and implement corrective actions.
• Develop, execute, and monitor corrective action plans to address quality concerns and drive sustainable improvements.
• Leverage enterprise tools to ensure regulatory compliance and streamline quality processes.
• Collaborate across functions to promote continuous improvement and operational excellence.
• Demonstrate ability to manage multiple priorities and lead organizational change.

Skills

Quality Engineering

CAPA management

SPC

Six Sigma

Root cause analysis

Documentation

Cross-functional collaboration

Education

Bachelor's degree in sciences

Tools

Minitab

Job description

Waters is seeking a Senior Quality Engineer to ensure compliance with Quality System, ISO, and FDA requirements by developing and implementing SOPs, quality policies, and process controls across plant operations. You will drive improvements, support audits, manage CAPAs, and lead product launches with cross-functional teams.

The role emphasizes data-driven decisions using SPC and root cause analysis, requires a bachelor’s degree in sciences and 3 years of quality engineering experience in a