Lead Quality Engineer, Regulatory & Process Excellence

Becton Dickinson NA; Sparks Corner (MD); On-site; USD 118,000 - 189,000; Full time

Job summary

Waters is seeking a quality-focused professional to lead interpretation and implementation of Quality System requirements in a regulated manufacturing/validation environment. You will develop SOPs, manage schedules, and ensure compliant documentation while driving continuous improvement and supporting audits.

Required are a Bachelor’s with 7+ years or a Master’s with 5+ years in regulated settings. On-site collaboration is emphasized to sustain a culture of excellence.

Qualifications

• Bachelor's degree with 7+ years in a regulated environment.
• Master's degree with 5+ years in a regulated environment.

Responsibilities

• Interpret and apply Quality System requirements and develop SOPs and policies for manufacturing or validation environments.
• Build, manage, and maintain project schedules to ensure timely execution and delivery.
• Ensure all documentation processes comply with regulatory and quality standards.
• Provide guidance across core Quality System elements, including process control and supplier qualification, while driving continuous improvement.
• Use statistical tools to identify root causes, drive corrective actions, and resolve quality issues.
• Support internal and external audit activities and ensure readiness.

Skills

Quality leadership

SOP development

Regulatory compliance

Statistical analysis

Education

Bachelor's degree

Master's degree

Job description

Waters is seeking a quality-focused professional to lead interpretation and implementation of Quality System requirements in a regulated manufacturing/validation environment. You will develop SOPs, manage schedules, and ensure compliant documentation while driving continuous improvement and supporting audits.

Required are a Bachelor’s with 7+ years or a Master’s with 5+ years in regulated settings. On-site collaboration is emphasized to sustain a culture of excellence.