Serve as the focal point for all quality-related issues at the affiliate level, providing expertise in Quality Assurance to ensure compliance with corporate standards and regulatory requirements
Oversee quality systems and operating standards at the site, country, or regional level
Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
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Oversaw non-conformance management (NCR) and Material Review Board (MRB) processes to ensure timely resolution and proper disposition of quality issues.
Conducted regular process audits and supported customer and ISO 9001 compliance audits, while driving continuous improvement through SPC, OCAP, and PFMEA activities.
Strong expertise in quality engineering tools and methodologies, including 8D, RCCA, PFMEA, SPC, and CAPA within a manufacturing environment.
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Conducted supplier audits, qualification processes, and performance evaluations, including scorecard monitoring and continuous improvement initiatives.
Collaborated with cross-functional teams and suppliers to resolve quality issues, support supplier development, and ensure compliance with customer and regulatory requirements.
Strong understanding of supplier quality management, including NCR handling, RCCA/8D methodologies, and “Copy Exactly” principles.
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• Monitor systems and processes, perform audits and inspections, identify issues, and implement corrective actions to maintain product quality and safety
• Serve as the focal point for all quality-related issues at the affiliate level, providing expertise in Quality Assurance to ensure compliance with corporate standards and regulatory requirements
• Oversee quality systems and operating standards at the site, country, or regional level
...
Ensure the company fulfills all MIDA compliance conditions, including the 80% local workforce ratio and the 25% Managerial, Technical, and Supervisory (MTS) staff threshold.