Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Summary :
We are seeking an experienced Quality Engineer, who you will be one the key on-site points of contact for quality issue management.
The Quality Engineer is responsible for qualification, triage, management and dispatch of incoming quality issues, working directly with Suppliers, Inspectors, Supplier Management and management. Key activities include ensuring the proper management of the overall quality process, ensuring adherence to quality metrics and standards, and leading continuous improvement initiatives.
Roles & Responsibilities:
Quality Issue Management :
• Serve as the primary on-site point of contact for incoming quality issues
• Qualify, triage, and dispatch quality issues to appropriate teams
• Conduct systematic root cause analysis using methodologies such as 5-Why, fishbone diagrams, 8D, or FMEA to determine underlying causes of quality issues
• Document quality issues in appropriate tracking systems
Supplier Quality Management :
• Reach out to suppliers to address and resolve quality issues
• Collaborate with suppliers to develop and implement corrective action plans
• Verify effectiveness of supplier corrective actions
Quality Documentation & Analysis :
• Analyze quality documentation to ensure compliance with standards and specifications
• Identify patterns or trends in quality issues and propose relevant solutions
• Develop, maintain, and update technical documentation including SOPs, Work Instructions, and Job Aids by working directly with subject matter experts to accurately capture complex processes
• Ensure documentation is clear, standardized, version-controlled, and compliant with internal quality systems and applicable regulatory requirements
Reporting & Communication :
• Ensure the right quality metrics are met and maintained
• Prepare and deliver regular quality performance reports to stakeholders
• Share outcomes of quality analyses at defined frequencies during review meetings
• Communicate effectively with internal teams and external partners regarding quality concerns
Continuous Improvement :
• Actively participate in improving day-to-day quality activities, reporting mechanisms, and methods
• Contribute to the development and refinement of Key Performance Indicators (KPIs)
Education & Experience :
• Bachelor's degree in engineering, Quality Assurance, or related technical field
• 5-10 years of experience in quality engineering, supplier quality management, or related roles
• Knowledge of quality management systems and standards
• Proficiency in root cause analysis methodologies and problem-solving techniques
• Experience in drafting quality processes & work instructions
• Strong analytical and documentation skills
• Excellent communication and interpersonal abilities