Intellectt Inc
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
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Engineering and Science
Industries
Medical Equipment Manufacturing
Pharmaceutical Manufacturing
Biotechnology Research
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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
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Engineering and Science
Industries
Medical Equipment Manufacturing
Pharmaceutical Manufacturing
Biotechnology Research
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