GTT, LLC
Overview
The
QA Compliance Specialist
supports the execution of
quality and regulatory functions
to maintain compliance with applicable regulations, standards, and corporate policies. This role ensures that the organization’s quality systems remain audit-ready, fully documented, and aligned with both corporate and industry requirements. The specialist will support audits, CAPA activities, documentation maintenance, metrics reporting, and continuous improvement initiatives across the quality system. Responsibilities
Support external audit activities, including
FDA, FDB, and ISO registrar audits . Audit areas of the Vascular Quality System for compliance with established standards. Support the administration of Quality System processes such as
CAPAs
and
Internal Audits . Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports. Track, trend, and report compliance activities, including CAPA and IACA metrics. Provide timely feedback to stakeholders on open corrective actions. Participate in cross-divisional activities to integrate and improve Quality System information. Review and update Quality System procedures as needed. Assist in developing and conducting
Quality System training . File and organize Quality Records such as audit reports, IACAs, and CAPAs. Ensure all responsibilities are carried out in full compliance with governing regulations and standards. Qualifications
Required Experience:
Bachelor’s Degree or equivalent. 4+ years of relevant QA, compliance, or quality systems experience. Hands-on experience with
CAPA processes, audits, and regulatory compliance . Nice-to-Have Experience:
Experience in medical device, pharmaceutical, diagnostics, or healthcare product environments. Experience with ISO, FDA, or global regulatory audits. Knowledge of cross-functional quality integration practices. Required Skills:
Quality System auditing, CAPA management, Regulatory compliance knowledge Preferred Skills:
Procedure writing and document control, Quality metrics development and reporting, Training development and delivery, Cross-functional communication Additional Skills:
Internal Audit Corrective Action (IACA) support, Quality record management, Trending and analysis of compliance data, Collaboration across divisions Benefits
Medical, Vision, and Dental Insurance Plans, 401k Retirement Fund Location & Contract Details
Location: Columbus, OH (On-site) Position Type: Contract Contract Duration: 12 months Start: As Soon As Possible Pay Rate: $41/hr
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The
QA Compliance Specialist
supports the execution of
quality and regulatory functions
to maintain compliance with applicable regulations, standards, and corporate policies. This role ensures that the organization’s quality systems remain audit-ready, fully documented, and aligned with both corporate and industry requirements. The specialist will support audits, CAPA activities, documentation maintenance, metrics reporting, and continuous improvement initiatives across the quality system. Responsibilities
Support external audit activities, including
FDA, FDB, and ISO registrar audits . Audit areas of the Vascular Quality System for compliance with established standards. Support the administration of Quality System processes such as
CAPAs
and
Internal Audits . Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports. Track, trend, and report compliance activities, including CAPA and IACA metrics. Provide timely feedback to stakeholders on open corrective actions. Participate in cross-divisional activities to integrate and improve Quality System information. Review and update Quality System procedures as needed. Assist in developing and conducting
Quality System training . File and organize Quality Records such as audit reports, IACAs, and CAPAs. Ensure all responsibilities are carried out in full compliance with governing regulations and standards. Qualifications
Required Experience:
Bachelor’s Degree or equivalent. 4+ years of relevant QA, compliance, or quality systems experience. Hands-on experience with
CAPA processes, audits, and regulatory compliance . Nice-to-Have Experience:
Experience in medical device, pharmaceutical, diagnostics, or healthcare product environments. Experience with ISO, FDA, or global regulatory audits. Knowledge of cross-functional quality integration practices. Required Skills:
Quality System auditing, CAPA management, Regulatory compliance knowledge Preferred Skills:
Procedure writing and document control, Quality metrics development and reporting, Training development and delivery, Cross-functional communication Additional Skills:
Internal Audit Corrective Action (IACA) support, Quality record management, Trending and analysis of compliance data, Collaboration across divisions Benefits
Medical, Vision, and Dental Insurance Plans, 401k Retirement Fund Location & Contract Details
Location: Columbus, OH (On-site) Position Type: Contract Contract Duration: 12 months Start: As Soon As Possible Pay Rate: $41/hr
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