Steven Tran

• Developed technical documentation, including standard operating procedures, work instructions, and engineering drawings to support manufacturing operations.
• Support in the scale up of the production floor
• Improved manufacturing efficiency by streamlining production processes and implementing lean methodologies.
• Reduced production downtime through proactive maintenance scheduling and timely equipment repairs.
• Optimized assembly line layouts to maximize productivity and improve overall workflow efficiency.
• Support the launch of new product.
• Maintain all processing equipment functionality and providing optimal yields.

· Support complaint handling by performing complaint investigations and investigations into investigational product.

· Submit MDR reports in a timely manner to ensure compliance with FDA requirements.

· Monitors laboratory and engineering equipment to ensure compliance with preventive maintenance and calibration programs.

· Maintains and updates equipment development, validation, and installation process.

· Reviews and understands quality regulations for audits, compliance, and implementation.

· Supports validations, performs testing, and updates QA/QC/process documentation.

· Perform corrective actions and root cause analysis

· Maintain design history files and device master record for RxSight products..

· Train associates on compliant procedures and practices for manufacturing and good documentation practices.

·Streamlined internal communication, fostering cross-functional collaboration between engineering, manufacturing, and quality teams.

· Maintain a rigorous environmental monitoring program to ensure FDA compliance.