Experience Requirements
Prior Quality Assurance management experience is required, including FDA, GMP, ISO, regulatory, facility, statistics and analysis, SPC, clean room microbiology and training programs is required. To perform this position function successfully, an individual must be able to perform each essential duty satisfactorily. Advanced computer skills are required. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Prior training GMP and Clean Room Procedures is required.
Qualification Requirements
This position requires advanced communications skills and advanced mathematics skills; leadership and flexibility, and the ability to generate a variety of instructions in written, oral, diagram or visual sample form, to determine methods for ensuring acceptability of finished goods, WIP product and received goods.
Preferred Qualifications
Prior medical manufacturing experience is desired.
Responsibilities
Develops, implements, and coordinates product assurance program to prevent or eliminate defects in new or existing products by performing the outlined duties personally or through subordinate positions. Responsible for the regulatory affairs of the organization. Analyzes, evaluates, and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products for consideration by other members of management team. Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities. Cooperates with other management personnel in formulating and establishing company policies, operating procedures, and goals. Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements, and operational procedures within program. Evaluates contents of reports from quality assurance initiatives and confers with management personnel preparatory to revisions to product assurance program. Conducts management meetings with associated staff to establish, delineate, and review organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives. Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures. Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards. Confers with engineers about quality assurance aspects of manufactured products. Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry. Coordinates and facilitates customer and corporate compliance audit visits. Prepares and submits required corporate reports relative to quality reporting, and general regulatory compliance. Maintains the internal audit system. Maintains the calibration of all measuring and test equipment used to accept product. Compiles and disburses yield analysis data as a continuous improvement tool. Oversees and maintains the documentation system. Provides support to the evaluation and quoting of new business opportunities via project and specification review, project and costing analysis and associated negotiations with new and existing customers. Travels as required to support all objectives of the position. Understands the location and purpose of Material Safety Data Sheets. Aware of the first aid supplies location. Aware of all emergency procedures. Maintains a clean and safe work environment. Keeps work area clean of debris. Performs other duties as assigned.
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