SUMMARY: This position works in support of the company’s Quality Assurance Department. The scope of this position includes: Demonstrating technical ability in Receiving Inspection Department and assisting and developing cross-functional training programs. The QC Inspector is required to have technical knowledge of all quality standards. The position functions in a fast-paced, high-energy environment while prioritizing multiple tasks and maintaining the highest level of compliance and quality. This position also performs a range of administrative tasks and office systems functions. ESSENTIAL DUTIES AND RESPONSIBILITIES:
Inspect, test, examination, measurement, of raw materials, components, sub-assemblies, final assemblies and documentation.
Perform visual, dimensional, and functional inspection of more complex components and/or finished medical device products using a wide variety of tools and equipment such as calipers, micrometers, depth gauges, CMM, or optical competitor, etc. to ensure conformance with design specifications and drawings – working at a level of greater independence with a higher level of productivity.
Understand engineering drawings and inspection requirements of components and parts with the capability of utilizing small hand-tools, test fixtures and must be able to train other inspectors.
Serves as subject matter expert for receiving inspection activities.
Assists Quality Assurance Engineer, purchasing department and production with day to day receiving inspection activities.
Develops, leads, and participates in Quality Department continuous improvement projects.
Works as a team player with other internal customers such as production, planning.
Performs all duties and assignments in a timely and accurate manner, in compliance with all quality system, GMP, and company policies.
Partake in developing and conducting training for QC department.
EDUCATION and/or EXPERIENCE:
High school graduate or GED; and/or minimum 3-5 years related experience in a FDA, ISO regulated industry. Electromechanical medical device manufacturing desired;
Quality Inspector Certificate a plus
Proficient knowledge of component testing/receiving inspection, product testing, in-process inspection and record compilation
Good working knowledge of inspection tools, (i.e, Calipers, Micrometers, Pin-gauges, Optical Comparator, and Coordinate Measuring Machine (CMM)
Good understanding of Good Manufacturing Practice, (GMP)
Must be Organized and be able train other inspectors