KMC Systems, a wholly-owned subsidiary of and co-located with Elbit Systems of America, is a leading contract designer and manufacturer of medical devices and instrumentation for OEM’s in the areas of diagnostic, therapeutic, and biomedical products. With more than 25 years of experience, KMC is an ISO 13485 certified and FDA registered firm with expertise in all aspects of product development, verification, design for and transition to production. Additional capabilities include flexible turnkey manufacturing, depot and field service repair and full compliance with FDA QSR regulations and GMP practices.
Elbit Systems of America (ESA) is a world leader in the design and manufacture of avionics flight instruments, technologically sophisticated defense systems and diagnostic medical instrumentation. ESA combines the close-knit teamwork and high visibility of a small company with the stability and resources only a large company can provide. Add in our employee-friendly corporate culture and great southern New Hampshire lifestyle, and you’ll see why joining ESA could be the best move of your career.
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):
Job ID 2018-6743