The position is responsible for ensuring compliance with regulatory standards and maintaining a quality management system.
Job Responsibilities:
• Perform production audits, inspections, and verify adherence to Good Manufacturing & Documentation Practices (GMP/GDP).
• Manage non-conforming materials and support root cause analysis of issues.
• Maintain and report quality metrics to ensure continuous improvement.
• Assist in documentation, process improvements, and lean initiatives to enhance efficiency.
• Support internal/external audits and regulatory compliance activities.
Requirements:
• Bachelor's degree in a quality-related field or equivalent experience.
• At least 25 years of experience in regulated manufacturing environments, preferably in medical devices or pharmaceuticals.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.
• Excellent communication and documentation skills.
• Proficiency in Microsoft Office applications.