Quality Assurance Compliance Specialist

Job Title: QA Compliance Specialist

Location: Columbus, OH

Contract type: W2

Shift: 8:30 AM – 5:00 PM

Job Summary:

We are seeking a QA Compliance Specialist to support quality and regulatory compliance activities within a regulated medical device environment. This role is responsible for ensuring quality system processes comply with applicable regulatory requirements, international standards, and corporate policies. The ideal candidate will have hands-on experience supporting audits, CAPA management, and quality system administration.

Key Responsibilities:

• Support external regulatory and certification audits, including FDA and ISO registrar audits
• Conduct audits of Quality System processes to ensure ongoing compliance
• Support the administration and maintenance of Quality System processes, including CAPA and Internal Audits
• Generate, track, and distribute reports related to open CAPAs and Internal Audit Corrective Actions
• Track, trend, and analyze compliance activities and quality metrics to support Management Reviews
• Assist teams in obtaining timely feedback and closure on corrective and preventive actions
• Participate in cross-functional and cross-divisional quality initiatives to align quality system information
• Review, update, and maintain Quality System procedures and documentation as required
• Assist in developing and delivering Quality System training programs
• Maintain and file Quality Records, including audit reports, CAPAs, and corrective action documentation
• Ensure all activities are conducted in compliance with applicable regulations, standards, and internal procedures
• Perform additional duties as assigned to support quality and compliance objectives

Required Qualifications:

• Bachelor’s degree or equivalent combination of education and relevant work experience
• Minimum of 4 years of experience in Quality Assurance, Compliance, or a regulated industry environment
• Strong knowledge of quality system requirements and regulatory standards
• Experience supporting audits, CAPA management, and quality documentation processes
• Strong organizational, analytical, and communication skills

Preferred Qualifications:

• Experience in medical device or other highly regulated manufacturing environments
• Familiarity with FDA Quality System Regulations and ISO standards