Engineer

• Design, analyze and implement operational workflows across US operations and supply chain.
• Identify opportunities for process improvements and participate in continuous improvement initiatives.
• Develop and maintain technical process documentation, including Standard Operating Procedures, Work Instructions and Process Maps.
• Gather and report process metrics.
• Develop and maintain procedures that ensure compliance to ISO13485 for Operations Projects that fall under the scope of the OrganOx Quality Management System (QMS).
• Create and review Specifications, Standard Operating Procedures and Work Instructions.
• Work closely with the Regulatory Affairs and Quality departments to ensure compliance with relevant medical device regulations.
• Create and review Change Controls (CCs), Risk Assessments (RAs), Root Cause Analysis investigations, Supplier Corrective Action Reports (SCARs), Nonconformance Reports (NCs), Corrective and Preventive Actions (CAPAs) and other internal & external documentation needed to support US Operations.
• Work collaboratively with colleagues at all levels in all departments to improve current processes and develop a culture of continuous improvement.
• Participate in the execution of US Operations Projects and work with cross functional teams to ensure successful execution.
• Support implementation of continuous improvement opportunities throughout the scope of operation for OrganOx Inc with the objective of improving Safety, Quality, Delivery performance and Cost.
• Collect and analyze process data and recommend improvements.

Senior Process Engineer

Senior Bridge Engineer

Lead SIEM Engineer

Release Train Engineer

Lead Kafka Engineer

CyberArk Engineer