Senior Quality Engineer – Med Devices & Compliance

Regulatory Jobs; Maryland; On-site; USD 96,000 - 153,000; Full time

Job summary

Waters Corporation is seeking a Quality Engineer to monitor quality indicators for materials and products, drive improvements, and ensure compliance with ISO and FDA requirements in a regulated manufacturing environment.

You will collaborate with the Plant Senior Quality Manager to ensure consistent Quality System implementation across product lines, coordinate CAPA, audits, and continuous improvement projects, and apply SPC and Six Sigma methods to data-driven improvements.

Qualifications

• Bachelor’s degree in sciences or other relevant technical field.
• 3 years’ experience in Quality Engineering or related field.
• Experience in a medical device, pharmaceutical manufacturing facility, or related manufacturing field.

Responsibilities

• Monitor, analyze, and trend quality indicators for purchased materials, as well as manufactured and distributed components and products, to drive product quality and performance improvements.
• Evaluate Critical to Quality (CTQ) parameters and risk assessment variables to support informed decision-making, predictable product design, and efficient product flow.
• Serve as a key Quality Management (QM) Engineering resource, supporting both Media QM Engineering initiatives and day-to-day quality engineering activities for assigned products and operational areas.
• Partner with the Plant Senior Quality Manager to ensure consistent implementation of Quality Systems across new and existing product lines and Enterprise systems.
• Support compliance with ISO, FDA, and internal quality requirements through audits, cross-functional collaboration, project support, product launches and transfers, process improvement initiatives, CAPA coordination, and customer complaint investigations.
• Utilize root cause analysis methodologies and quality tools to identify issues, drive investigations, and implement effective corrective and preventive actions.
• Develop, execute, and monitor corrective action plans to address quality concerns and drive sustainable improvements.
• Leverage Enterprise tools and systems to ensure regulatory compliance, improve visibility, and streamline quality processes.
• Collaborate across functions to promote continuous improvement and support operational excellence.
• Demonstrate the ability to proactively manage multiple priorities and lead key initiatives.
• Lead and support process control, supplier quality, and continuous improvement projects.
• Apply statistical methods and quality tools, including SPC, to analyze performance, identify trends, and implement data-driven improvements.
• Collaborate with cross-functional teams to identify opportunities for process optimization, problem-solving, and sustainable quality improvements.

Skills

Quality Engineering

FDA 21 CFR 820

ISO 13485

Six Sigma

Lean Tools

Root Cause Analysis

Project Management

Communication Skills

Data Analysis

Education

Bachelor’s degree in sciences

Tools

Minitab

Job description

Waters Corporation is seeking a Quality Engineer to monitor quality indicators for materials and products, drive improvements, and ensure compliance with ISO and FDA requirements in a regulated manufacturing environment.

You will collaborate with the Plant Senior Quality Manager to ensure consistent Quality System implementation across product lines, coordinate CAPA, audits, and continuous improvement projects, and apply SPC and Six Sigma methods to data-driven improvements.