Quality Engineer II — QMS, CAPA & Compliance

Becton Dickinson NA; Sparks Corner (MD); On-site; USD 96,000 - 153,000; Full time

Job summary

BD (Becton, Dickinson, and Company) in Sparks, MD is seeking a Quality Engineering II to develop, implement, and maintain the Quality Management System (QMS) and ensure regulatory compliance in a life sciences manufacturing setting. You will drive quality improvements, CAPA, and risk mitigation across product lifecycles.

The role emphasizes root-cause analysis, CAPA implementation, and cross-functional collaboration with R&D, Manufacturing, and Regulatory Affairs to uphold cGMP, ISO 13485, and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3-5 years in Quality Engineering within a regulated industry.
• Strong knowledge of QMS principles and CAPA.
• Familiarity with SPC and quality tools.
• Excellent written and verbal communication skills.

Responsibilities

• Lead and participate in investigations of non-conformances, deviations, and out-of-spec results, identifying root causes and implementing CAPA.
• Develop, review, and approve quality documentation including procedures, specifications, and test methods.
• Support validation activities for equipment, processes, and software, including protocol and report generation and execution oversight.
• Perform risk assessments and develop mitigation strategies to ensure product quality and patient safety.
• Contribute to internal and external audit programs, including participation in audit prep, execution, and follow-up.
• Analyze quality data and trends to identify areas for improvement and propose solutions.
• Collaborate with cross-functional teams to integrate quality by design throughout the product lifecycle.
• Provide training and mentorship on quality principles and procedures.
• Ensure adherence to cGMP, ISO 13485, FDA, and other applicable regulatory standards.

Skills

Root cause analysis

CAPA implementation

QMS principles

ISO 13485 knowledge

FDA 21 CFR Part 820

ASQ CQE

MS Office

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office

Job description

BD (Becton, Dickinson, and Company) in Sparks, MD is seeking a Quality Engineering II to develop, implement, and maintain the Quality Management System (QMS) and ensure regulatory compliance in a life sciences manufacturing setting. You will drive quality improvements, CAPA, and risk mitigation across product lifecycles.

The role emphasizes root-cause analysis, CAPA implementation, and cross-functional collaboration with R&D, Manufacturing, and Regulatory Affairs to uphold cGMP, ISO 13485, and