Quality Systems & CAPA Specialist II – Audits & Compliance

BD; Sumter (SC); On-site; USD 70,000 - 80,000; Full time

Job summary

BD is a leading global medical technology company focused on advancing health through innovative solutions. The Quality System Specialist II will manage corrective/preventive actions, internal audits, and customer complaints to ensure FDA and ISO compliance across the plant's operations.

Reporting to the Quality Manager, Quality Systems, you will lead investigations, analyze trends, and coordinate CAPA activities to sustain high-quality production and regulatory alignment.

Qualifications

• High School Diploma or GED required.
• 2-3 years related work experience preferred.
• Experience with quality systems and regulatory requirements is desirable.

Responsibilities

• Leads and facilitates investigations of customer complaints and captures root cause analysis.
• Analyzes complaint data and tracks trends to identify significant changes.
• Documents CAPA activities and maintains files per procedures.
• Performs internal and external audits and supports audit reporting.
• Coordinates corrective and preventive actions to ensure effectiveness.
• Participates in site quality training and regulatory compliance activities.
• Manages the plant's CAPA system to ensure accuracy of specifications and procedures.
• Supports regulatory and corporate directives related to FDA/ISO standards.

Skills

CAPA leadership

Audit coordination

Root cause analysis

Regulatory compliance

Education

High School Diploma or GED

Job description

BD is a leading global medical technology company focused on advancing health through innovative solutions. The Quality System Specialist II will manage corrective/preventive actions, internal audits, and customer complaints to ensure FDA and ISO compliance across the plant's operations.

Reporting to the Quality Manager, Quality Systems, you will lead investigations, analyze trends, and coordinate CAPA activities to sustain high-quality production and regulatory alignment.