What are the responsibilities and job description for the Quality Assurance Compliance Specialist position at Intellectt Inc?
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