Senior Quality Engineer — Regulated Manufacturing

Becton Dickinson; United States; On-site; USD 140,000 - 180,000; Full time

Job summary

Waters is seeking a senior Quality Leader to interpret and apply Quality System requirements in a regulated manufacturing or validation setting. You will develop and implement SOPs, drive continuous improvement, and ensure robust documentation practices.

In this role, you will lead quality initiatives, guide supplier qualification, support audits, and apply advanced quality engineering principles to deliver compliant, validated results in a fast-paced environment.

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 implement SOPs in manufacturing or validation environments.
• Build and manage project schedules to ensure timely delivery.
• Ensure documentation processes comply with regulatory standards.
• Provide guidance on core Quality System elements and supplier qualification.
• Use statistical tools to identify root causes and drive corrective actions.
• Support internal and external audits and ensure readiness.
• Apply advanced quality engineering principles to deliver validated results.

Skills

Quality leadership

Regulatory compliance

Statistical analysis

Process improvement

Documentation control

Education

Bachelor's degree

Master's degree

Job description

Waters is seeking a senior Quality Leader to interpret and apply Quality System requirements in a regulated manufacturing or validation setting. You will develop and implement SOPs, drive continuous improvement, and ensure robust documentation practices.

In this role, you will lead quality initiatives, guide supplier qualification, support audits, and apply advanced quality engineering principles to deliver compliant, validated results in a fast-paced environment.