Quality Assurance Specialist 5734
Plan, devise and implement Quality Assurance standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned complex project or area to assure the highest quality levels and cost?effective compliance with contractual and KMC Systems requirements. Develops test techniques and procedures as required.
Develop and establish Quality Assurance programs and process control methodologies to provide and maintain the highest quality levels for an assigned project, product or area in accordance with contract requirements and product specifications.
Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of assigned products or production equipment.
Conduct experiments and audits to evaluate operating characteristics of products or processes. Devise applications of engineering technology to define and solve operational problems. Evaluate data from experiments and prepare reports and summaries outlining results and recommend revisions or modifications to systems to maintain or improve product quality.
Analyze statistical data to evaluate trends and investigate failures completely to determine the root cause. Take appropriate company or vendor corrective action to revise design, methods or inspection/test instructions to prevent failure recurrence.
Evaluate and monitor quality of vendor services and goods and recommend selection of optimum vendors. Initiate vendor corrective action activities.
Serve as member of Material Review and Configuration Control Boards.
Design standard, more complex equipment for testing company products, and related sub?systems, and for assuring the completeness and accuracy of manufacturing processes. Specify the design and fabrication of components and assemblies.
Analyze test program specifications and manufacturing processes and recommend the type of test and test equipment necessary to accomplish objective.
Assist in the design of the more complex equipment for testing products and prepare schematic drawings and complete parts lists; issues work orders for production of equipment as designed and follows up on construction.
Perform special studies and assignments as designated.
A Bachelor's degree and 4-6 years related experience to be proficient in the above areas or an equivalent combination of education and experience.
Experience in an FDA regulated environment is highly preferred.