Quality Engineer III – MedTech Quality & Compliance

Regulatory Jobs; Cockeysville (MD); On-site; USD 96,000 - 153,000; Full time

Job summary

Waters Corporation is seeking a Quality Engineering professional to monitor, analyze, and improve quality for materials and products in a regulated manufacturing environment in Hunt Valley, MD. The role partners with the Plant Senior Quality Manager to implement Quality Systems and ensure ISO 13485 and FDA regulatory compliance.

You will lead root-cause investigations, CAPA, and process improvements across multiple product lines.

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 or pharmaceutical manufacturing environment.
• Moderate knowledge of FDA 21 CFR 820, ISO 13485, and 14971.
• Minitab experience is a plus.
• Familiarity with Six Sigma, Lean tools, root cause analysis, and project management techniques.

Responsibilities

• Monitor quality indicators for purchased materials, manufactured components, and products to drive quality improvements.
• Evaluate CTQ parameters and risk assessment variables to support informed decision-making and efficient product flow.
• Provide QM Engineering support for assigned products and operations areas.
• Partner with the Plant Senior Quality Manager to ensure Quality Systems are applied consistently across product lines.
• Support ISO, FDA and internal quality requirements through audits, CAPA coordination, and product quality notifications.

Skills

Communication skills

FDA 21 CFR 820 knowledge

ISO 13485 knowledge

Minitab

Six Sigma

Lean tools

Project management

Education

Bachelor's degree in sciences/relevant technical field

Job description

Waters Corporation is seeking a Quality Engineering professional to monitor, analyze, and improve quality for materials and products in a regulated manufacturing environment in Hunt Valley, MD. The role partners with the Plant Senior Quality Manager to implement Quality Systems and ensure ISO 13485 and FDA regulatory compliance.

You will lead root-cause investigations, CAPA, and process improvements across multiple product lines.