What are the responsibilities and job description for the QA Compliance Specialist position at Global Technical Talent, an Inc. 5000 Company?
QA Compliance SpecialistAlternate/Related Job Titles:
- Quality Systems Compliance Specialist
- Regulatory Compliance Analyst
- Quality Assurance Auditor
On-site Flexibility: On-siteContract Details:
- Position Type: Contract
- Contract Duration: 12 months
- Start: As Soon As Possible
- Pay Rate: $41/hr
- 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.
- 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.
- 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.
- Quality System auditing
- CAPA management
- Regulatory compliance knowledge
- Procedure writing and document control
- Quality metrics development and reporting
- Training development and delivery
- Cross-functional communication
- Internal Audit Corrective Action (IACA) support
- Quality record management
- Trending and analysis of compliance data
- Collaboration across divisions
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
Salary : $41