Quality Engineer II – Regulated Life Sciences (CAPA & QMS)

BD Mexico; Sparks Corner (MD); On-site; USD 96,000 - 153,000; Full time

Job summary

BD, a leading global medical technology company, seeks a Quality Engineering II to support the Quality Management System within a life sciences manufacturing setting, ensuring compliance and continuous improvement.

You will drive CAPA, perform risk assessments, engage with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) and mentor junior staff, all while maintaining rigorous data analysis and adherence to cGMP and ISO 13485 standards to protect patient safety.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3–5 years of experience in a Quality Engineering role within a regulated industry.
• Strong understanding of QMS principles and practical application.
• Experience with root cause analysis methods (e.g., 5 Whys, Fishbone) and CAPA implementation.
• Familiarity with SPC and other quality improvement tools.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite.
• Ability to work independently and in a team in a fast-paced environment.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 preferred.
• ASQ certification (e.g., CQE) is a plus.

Responsibilities

• Lead and participate in investigations of non-conformances, deviations, and out-of-specification results; identify root causes and implement 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.
• Perform risk assessments and develop mitigation strategies to ensure product quality and patient safety.
• Contribute to internal and external audit programs, including preparation, execution, and follow-up.
• Analyze quality data and trends to identify improvement opportunities and propose solutions.
• Collaborate with R&D, Manufacturing, Regulatory Affairs to integrate quality by design across the product lifecycle.
• Provide training and mentorship on quality principles to junior staff.
• Ensure adherence to cGMP, ISO 13485, FDA 21 CFR Part 820.

Skills

QMS principles

Root cause analysis

CAPA

SPC

Documentation

Communication

MS Office

Regulated industry

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Microsoft Office

QMS software

Job description

BD, a leading global medical technology company, seeks a Quality Engineering II to support the Quality Management System within a life sciences manufacturing setting, ensuring compliance and continuous improvement.

You will drive CAPA, perform risk assessments, engage with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) and mentor junior staff, all while maintaining rigorous data analysis and adherence to cGMP and ISO 13485 standards to protect patient safety.