Senior Quality Engineer – Medical Devices

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

Benefits offered by this job

On-site collaboration

Competitive compensation

Total Rewards program

Job summary

BD is seeking a Quality Engineer to monitor quality indicators across materials and products in a regulated medical device environment in Hunt Valley, Maryland. You will evaluate CTQ parameters, support QM engineering initiatives, and ensure compliance with ISO 13485, 14971, and FDA 21 CFR 820.

The role requires a bachelor's degree in a scientific field and 3 years of experience in quality engineering or related area, with strong problem-solving skills and experience with Minitab, Six Sigma, and

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 other relevant manufacturing field.

Responsibilities

• Monitor, analyze, and trend quality indicators for materials and products to drive quality improvements.
• Evaluate CTQ parameters and risk to support informed decision-making and efficient product flow.
• Support QM Engineering initiatives and day-to-day quality engineering activities.
• Partner with Plant Senior Quality Manager to ensure Quality Systems across product lines and Enterprise systems.
• Assist with audits, CAPA coordination, product launches and transfers, and change notifications to maintain compliance.
• Use root cause analysis and quality tools to identify issues and implement corrective actions.
• Develop, execute, and monitor corrective action plans for quality concerns.
• Leverage Enterprise tools to improve regulatory compliance and visibility of quality processes.
• Collaborate across functions to promote continuous improvement and operational excellence.

Skills

Quality Engineering

FDA 21 CFR 820

ISO 13485

ISO 14971

Minitab

Six Sigma

Lean Tools

Root Cause Analysis

Project Management

Communication Skills

Education

Bachelor's degree in sciences or relevant field

Job description

BD is seeking a Quality Engineer to monitor quality indicators across materials and products in a regulated medical device environment in Hunt Valley, Maryland. You will evaluate CTQ parameters, support QM engineering initiatives, and ensure compliance with ISO 13485, 14971, and FDA 21 CFR 820.

The role requires a bachelor's degree in a scientific field and 3 years of experience in quality engineering or related area, with strong problem-solving skills and experience with Minitab, Six Sigma, and