Quality Systems & CAPA Specialist

Becton, Dickinson and Company; Sumter (SC); On-site; USD 55,000 - 75,000; Full time

Job summary

BD is a large global medical technology company focused on advancing health. The Quality System Specialist II supports FDA and ISO compliance, manages CAPA and internal audits, and drives corrective/preventive actions across the plant.

The role involves handling customer complaints, root cause analysis, data trending, and training to maintain high quality standards. The position reports to the Quality Manager, Quality Systems, and emphasizes a strong compliance culture with opportunities to

Qualifications

• High School Diploma or GED required with 2-3 years related work experience preferred.
• Experience with FDA and ISO compliance is a plus.
• Knowledge of CAPA, audits and quality systems.

Responsibilities

• Evaluate customer complaints and lead investigations to identify root causes.
• Analyze complaint data and identify trends and chronic issues.
• Document all activities related to complaint analysis, CAPA and investigation.
• Handle returned samples safely and dispose of contaminated items.
• Audit corrective actions for effectiveness.
• Participate in internal/external audits and report findings.
• Conduct quality training to ensure regulatory compliance.
• Manage the plant CAPA system to ensure accuracy of procedures.
• Manage the internal audit program to ensure regulatory compliance.
• Plan and perform plant system audits and coordinate audit teams.
• Conduct supplier audits to ensure QSR/ISO compliance as directed.

Skills

Root cause analysis

CAPA management

Internal audits

FDA compliance

ISO compliance

Documentation

Quality training

Problem solving

Education

High School Diploma or GED

Tools

QMS

Job description

BD is a large global medical technology company focused on advancing health. The Quality System Specialist II supports FDA and ISO compliance, manages CAPA and internal audits, and drives corrective/preventive actions across the plant.

The role involves handling customer complaints, root cause analysis, data trending, and training to maintain high quality standards. The position reports to the Quality Manager, Quality Systems, and emphasizes a strong compliance culture with opportunities to