Quality Engineer Lead – Regulatory & Process Improvement

BD; Sparks Corner (MD); On-site; USD 110,000 - 160,000; Full time

Job summary

BD is a leading global medical technology company focused on delivering quality systems in regulated environments. Join us to lead quality initiatives, develop SOPs, and ensure compliance in manufacturing or validation settings.

This role emphasizes applying quality engineering principles, supporting audits, and driving continuous improvement. On-site collaboration in MD Sparks, with a strong emphasis on documentation, supplier qualification, and data-driven problem solving.

Qualifications

• Bachelor's degree and 7 years experience in a regulated environment.
• Master's degree and 5 years experience in a regulated environment.

Responsibilities

• Interpret and apply Quality System requirements and develop SOPs in manufacturing/validation.
• Build, manage, and maintain project schedules and timelines for delivery.
• Ensure documentation processes comply with regulatory and quality standards.
• Provide guidance across Quality System elements including process control and supplier qualification.
• Use statistical tools to identify root causes, drive corrective actions, and resolve quality issues.
• Support internal and external audit activities and compliance readiness.
• Apply advanced quality engineering principles to deliver validated results.

Skills

Quality leadership

SOP development

Regulated environment

Documentation

Audit support

Education

Bachelor's degree

Master's degree

Tools

Statistical software

Job description

BD is a leading global medical technology company focused on delivering quality systems in regulated environments. Join us to lead quality initiatives, develop SOPs, and ensure compliance in manufacturing or validation settings.

This role emphasizes applying quality engineering principles, supporting audits, and driving continuous improvement. On-site collaboration in MD Sparks, with a strong emphasis on documentation, supplier qualification, and data-driven problem solving.