Quality Engineer II - MedTech Quality & Compliance

Becton Dickinson NA; Cockeysville (MD); On-site; USD 76,000 - 121,000; Full time

Job summary

Waters Corporation is seeking a Quality Engineer to develop, implement, and maintain Quality System procedures, SOPs, and quality policies in a regulated, high-volume environment. You will lead validation activities, monitor quality indicators, perform risk assessments, and drive CAPAs with cross-functional teams.

The role requires strong data analysis, knowledge of FDA/ISO standards, and the ability to communicate clearly.

Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, or related field.
• 2 years experience in Quality, Scientific Operations, or Engineering.

Responsibilities

• Develop, implement, and maintain Quality System procedures, SOPs, and quality policies.
• Lead and execute validation activities, including change validations and recurring process/equipment qualifications for Media plants and IDAST.
• Monitor, trend, and analyze quality indicators for purchased materials, manufactured products, and distributed components.
• Assess Critical to Quality (CTQ) parameters and perform risk assessments to support product quality and decision-making.
• Apply statistical tools and data analysis techniques to identify root causes, resolve quality issues, and implement effective corrective actions.
• Initiate and support CAPAs, including leading investigations and corrective action activities when required.
• Support process control initiatives and promote consistent manufacturing practices across operations.
• Identify and recommend continuous improvement opportunities to enhance product quality, operational efficiency, and compliance.
• Manage day-to-day QM Engineering activities for assigned products and projects.
• Partner with manufacturing, engineering, and cross-functional teams to support product launches and quality initiatives.
• Ensure consistent implementation of Quality Systems for new and existing product lines.
• Maintain compliance with FDA regulations, ISO standards, and other quality requirements.
• Support quality-related activities including change controls, product quality notifications, and customer complaint investigations.

Skills

Quality Systems

SOPs

Validation

CAPA

Risk Assessment

Statistical Tools

Root Cause Analysis

Documentation

Communication

Cross-functional Collaboration

Education

Bachelor's degree in Biological Sciences, Chemistry, or related field

Job description

Waters Corporation is seeking a Quality Engineer to develop, implement, and maintain Quality System procedures, SOPs, and quality policies in a regulated, high-volume environment. You will lead validation activities, monitor quality indicators, perform risk assessments, and drive CAPAs with cross-functional teams.

The role requires strong data analysis, knowledge of FDA/ISO standards, and the ability to communicate clearly.