Quality Engineer Lead – Regulated Manufacturing & Compliance

BD; Glencoe (KY); On-site; USD 100,000 - 160,000; Full time

Job summary

BD, a leading global medical technology company, is seeking a senior quality leader to interpret Quality System requirements and drive SOPs and policies within manufacturing or validation environments. You will manage schedules, ensure documentation compliance, and guide cross-functional teams in process control and supplier qualification.

The role emphasizes continuous improvement, data-driven problem solving, and audit readiness, all within an on-site, collaborative setting supported by strong

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/implement SOPs and policies in manufacturing or validation environments.
• Build, manage, and maintain project schedules and timelines for effective execution.
• Ensure documentation processes comply with regulatory and quality standards.
• Provide guidance across core Quality System elements, including process control and supplier qualification, and drive continuous improvement.
• Use statistical tools and data analysis to identify root causes and drive corrective actions for quality issues.
• Support internal and external audit activities and ensure readiness and compliance.
• Apply advanced quality engineering principles and quality science methodologies to deliver measurable results.

Job description

BD, a leading global medical technology company, is seeking a senior quality leader to interpret Quality System requirements and drive SOPs and policies within manufacturing or validation environments. You will manage schedules, ensure documentation compliance, and guide cross-functional teams in process control and supplier qualification.

The role emphasizes continuous improvement, data-driven problem solving, and audit readiness, all within an on-site, collaborative setting supported by strong