Senior Quality Engineer - Regulated Manufacturing & QA

RXinsider LTD.; Sparks Corner (MD); On-site; USD 118,000 - 189,000; Full time

Job summary

Waters Corporation is seeking a senior Quality Engineer to lead Quality System interpretation and implementation within manufacturing or validation settings. You will develop SOPs and policies, manage schedules, and ensure documentation compliance to regulatory standards.

You will guide process control, supplier qualification, and continuous improvement, using statistical tools to drive CAPA and support audits.

Qualifications

• Bachelor's degree in a regulated environment.
• Master's degree in a related field preferred.
• 7 years experience in a regulated environment or 5 with a Master’s degree.

Responsibilities

• Interpret and apply Quality System requirements in manufacturing or validation environments.
• Develop and implement SOPs and organizational policies.
• Build, manage, and maintain project schedules and timelines.
• Ensure documentation processes comply with regulatory standards.
• Provide guidance on process control, supplier qualification, and continuous improvement.
• Use statistical tools to identify root causes and drive CAPA.
• Support internal and external audit activities and readiness.

Education

Bachelor's degree

Master's degree

Job description

Waters Corporation is seeking a senior Quality Engineer to lead Quality System interpretation and implementation within manufacturing or validation settings. You will develop SOPs and policies, manage schedules, and ensure documentation compliance to regulatory standards.

You will guide process control, supplier qualification, and continuous improvement, using statistical tools to drive CAPA and support audits.