Anthony Arena Cmfgt

Quality Systems Improvement Engineer @SMC Ltd

Roseville, CA, US

Develop and implement continuous improvement strategies to enhance quality, efficiency, and cost-effectiveness in manufacturing processes including system level changes. • Analyze production data to identify trends, root causes of defects, and opportunities for process optimization using tools such as Six Sigma, Lean, or other methodologies. • Lead corrective and preventive action (CAPA) initiatives to address quality issues and ensure compliance with regulatory standards. • Collaborate with quality assurance, engineering, and production teams to design and validate process improvements, ensuring alignment with customer specifications and regulatory requirements. • Maintain and update quality documentation, including standard operating procedures (SOPs), work instructions, and process control plans, to ensure compliance with ISO 13485 and FDA regulations. • Train and mentor staff on quality standards, continuous improvement techniques, and best practices to foster a culture of quality. • Support system template development and implementation of new validation master plans, process validation, completion reports, and equipment / software validations at site.

California State University, Chico

B.S. Manufacturing Technology