Quality Compliance Expert

Overview

1. Technical Knowledge & Regulatory Expertise

• Regulatory Standards: In-depth understanding of industry-specific regulations (e.g., FDA, ISO,OSHA).
• Quality Management Systems (QMS): Familiarity with QMS principles and how to implement and audit them.
• Auditing: Skills in internal and external audits, including creating audit reports and ensuring compliance.
• Risk Management: Ability to identify, assess, and mitigate risks associated with non- compliance.

2. Analytical and Problem-Solving Skills

• Root Cause Analysis: Expertise in identifying issues, conducting investigations, and applying corrective/preventive actions (CAPA).

1. Quality Management System (QMS) Maintenance

• Develop, implement, and maintain the Quality Management System in accordance with industry standards (e.g., ISO 9001).
• Ensure that QMS documentation is current, accurate, and effectively implemented across the organization.

2. Regulatory Compliance

• Monitor and interpret regulations, standards, and guidelines from relevant regulatory bodies (e.g., FDA, ISO, OSHA).
• Ensure that products, processes, and systems comply with applicable regulatory requirements.
• Prepare and submit necessary documentation to regulatory authorities as required.

3. Audits and Inspections

• Plan, conduct, and manage internal and external audits to assess compliance with quality standards and regulatory requirements.
• Facilitate third-party audits, inspections, and certifications.
• Track audit findings and ensure timely closure of corrective and preventive actions
• (CAPA).
• **Experience**
• :
• ✓ Experience in a quality compliance or quality engineering role, preferably in a regulated industry (e.g., medical devices, pharmaceuticals, automotive).
• Professional Memberships and Certifications
• ✓ Certification in Quality Engineering (CQE) or Quality Management (CQM) is preferred.
• ✓ Strong knowledge of quality management systems (e.g., ISO 9001) and regulatory requirements.
• ✓ Experience with auditing, risk management, and continuous improvement methodologies.
• ✓ Excellent analytical, problem-solving, and communication skills.
• ✓ Proficiency in quality tools such as Six Sigma, FMEA, SPC, and root cause analysis.
• **Language Requirements**
• :
• ✓ Arabic and English
• Interested candidates send me your CV with below details.
• Expected salary: