Elbit Systems of America is a leading provider of high performance products, system solutions, and support services focusing on the defense, homeland security, commercial aviation, and medical instrumentation markets. With facilities throughout the United States, Elbit Systems of America is dedicated to supporting those who contribute daily to the safety and security of the United States. Elbit Systems of America, LLC is wholly owned by Elbit Systems Ltd. (NASDAQ: ESLT and TASE: ESLT), a global high technology company engaged in a wide range of programs for innovative defense and commercial applications. For additional information, visit: www.elbitsystems-us.com or follow us on Twitter.
Under the direction of the Q&R Director, is responsible for the maintenance of the Quality System and is considered the principal subject matter expert on Quality System Requirements, Regulatory Compliance, and Standards. Key objectives include maintaining QMS procedures and records, and overseeing the monitoring and measurement of the QMS (including Audits). Interfaces in a variety of capacities such as lead, host, or SME, etc with ISO audits, customer audits, and regulatory inspections. Responsible for corrective action tracking from audits or inspections. Responsible for the oversight, maintenance, and reporting for all ISO and regulatory documentation implementation, revision and incorporation into Company policies. Participates in concurrent engineering, assisting Program Quality in ensuring that all customer-related Quality System requirements above the Elbit Systems of America- Merrimack Quality System are documented and identified as specified by the Elbit Systems of America- Merrimack Quality System.
Ensure quality system compliance to ISO 13485, European regulatory directives/regulations such as MDD/IVDD, ISO 14971, RoHS, REACH, and applicable parts of 21CFR. Be able to identify standards and regulations that are applicable based on the product description obtained from the customer, and ensure these are captured in Requirements Documents.Monitor the Corrective Action process at the request of the Director of Q&R.
DESIRED SKILLS (not required):