Senior Quality Assurance Specialist
hace 1 semana
Quality Engineer Job Description
Overview
At Intellectt Inc, we are seeking a skilled Quality Engineer to join our team. This individual will play a critical role in ensuring that our manufacturing processes meet the highest quality standards and comply with regulatory guidelines.
Key Responsibilities
• Develop, implement, and maintain quality processes and systems
• Perform root cause analysis and corrective actions for quality-related issues
• Conduct audits to ensure compliance with ISO and FDA standards
• Collaborate with engineering and production teams to improve product quality
• Oversee non-conformance management, CAPA, and complaint investigations
• Support the validation of processes, equipment, and systems
• Monitor and analyze key quality metrics to identify improvement areas
Qualifications
• Bachelor's degree in Engineering, Quality, or related field
• 5+ years of experience in quality engineering in a regulated environment
• Experience with CAPA, NCR, and quality management systems (QMS)
• Knowledge of FDA and ISO regulations
• Strong attention to detail with excellent communication skills
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