Lead Quality Engineer - Regulatory & Process Excellence

BD Mexico; Sparks Corner (MD); On-site; USD 118,000 - 189,000; Full time

Job summary

Waters Corporation seeks a quality leader to interpret and apply Quality System requirements within manufacturing or validation environments, developing SOPs and policies. Lead cross‑functional teams to drive compliance and continuous improvement.

You will build and manage project schedules, ensure documentation meets regulatory standards, support internal and external audits, and apply quality engineering principles to deliver measurable results in a regulated life sciences setting.

Qualifications

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

Responsibilities

• Serve as a key quality leader responsible for interpreting and applying Quality System requirements and developing/implementing Standard Operating Procedures (SOPs) and organizational policies within manufacturing or validation environments
• Build, manage, and maintain project schedules and timelines to ensure efficient execution and delivery
• Ensure all documentation processes are compliant with applicable regulatory and quality standards
• Provide guidance across core Quality System elements, including process control and supplier qualification, while identifying and driving continuous improvement opportunities (both internal and external)
• Utilize statistical tools and data analysis techniques to identify root causes, drive corrective actions, and resolve moderately complex quality issues effectively
• Support internal and external audit activities, ensuring readiness and compliance
• Apply advanced quality engineering principles, technical concepts, and quality science methodologies to deliver measurable and validated results

Skills

Quality System

SOP Development

Regulatory Compliance

Root Cause Analysis

Statistical Methods

Audit Support

Project Scheduling

Documentation Control

Quality Engineering

Education

Bachelor's degree

Master's degree

Job description

Waters Corporation seeks a quality leader to interpret and apply Quality System requirements within manufacturing or validation environments, developing SOPs and policies. Lead cross‑functional teams to drive compliance and continuous improvement.

You will build and manage project schedules, ensure documentation meets regulatory standards, support internal and external audits, and apply quality engineering principles to deliver measurable results in a regulated life sciences setting.