The CFO reports directly to the President/CEO and is responsible for directing the fiscal functions for the organization in accordance with Generally Accepted Accounting Principles (GAAP) and the directives of applicable regulatory and advisory organizations. The CFO is a key decision maker as a member of the Executive team.
The Senior and Principal Quality Assurance (QA) Engineers actively promote and implement the Quality Management System by means of monitoring, evaluating and reporting of all quality related activities. The intent of all Quality Assurance activities is that of compliance with all regulatory requirements and standards, customer satisfaction and continuous quality improvement. The essential functions of the QA Engineer role consists of activities in 3 main areas: Quality Management System Support, Project Quality Assurance/Quality Engineering, and Manufacturing Quality Control.
The Program Manager oversees the coordination and administration of all aspects of an ongoing program, including planning, organizing, staffing, leading and controlling program activities.
The Project Manager (PM) takes charge of a specific project or projects within the organization. The position involves planning, budgeting, overseeing and documenting while managing team members working on projects under the PM’s scope of control. The PM works closely with upper management to ensure that the scope and direction of each project is on track and on schedule.
The Operator/Line Lead will produce quality product from multiple production areas and must be fully trained and capable of producing all part numbers. This team member will assist in training other team members in any work center, where he/she is a subject matter expert, and will train on the proper techniques and procedures to be followed in order to produce defect-free parts. The incumbent will help to identify best practices and teach best practices to other operators to reduce scrap and maintain product quality. In addition, the Operator/Line Lead will review schedules and make recommendations to the manager if an issue or concern is observed and be involved in continuous improvement projects.
The Principal Product Development Engineer leads or plays a prominent role in the development of medical device projects from conception, design and development of new products and their processes using design and development systems in accordance with FDA and international regulations.