ISO 13485

Quality Director- Two Manufacturing Locations Kerrville, TX and Addison, TX

This position is responsible for planning, managing and directing all aspects of the All-Plastics Quality Assurance Department.

This position reports to the President/CEO and is responsible for coordinating quality assurance through training and interfacing with employees and customers. This position will provide a quality system which will insure that the products designed, manufactured, and sold by All-Plastics meet all customer specifications and monitor the Quality system to ensure continued compliance.

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    The principal duties and responsibilities of the QA Director consist of, but are not limited to, the following:

    · Quality Culture – Responsible to take the leadership role in changing/maintaining the quality culture of the company. Acts as champion of quality throughout the organization. We serve as a visible model of quality.

    · Quality Improvement – Develop, lead, facilitate and participate in quality improvement teams. Responsible for motivating and generating teamwork within teams. Focus will be on defect prevention rather than defect detection.

    · Quality Conformance – Responsible for ensuring that all raw materials, produced product, and contract manufactured product conforms to quality standards. Provides support and recommendations on adjustments required for in-process production. Functions as ISO Management Representative and ensures continued ISO certification. Responsible for all departmental documentation.

    · Customer Service – Responsible for ensuring customer service through product quality. Serves as a primary contact with the customer. Maintains communication with customers by telephone, written communication and/or physical contact. Responsible for dealing with customers and suppliers in assuring quality and developing quality improvement programs. This position is responsible for implementing teams, which would recommend modifications to product specifications, process equipment, control equipment, all which are necessary to ensure satisfactory quality.

    · Supervision – Provide leadership, direction and management for Quality Improvement personnel. Ensures conformance with departmental objectives. Train team participants from other departments.

    · Decision Making – Responsible for the establishment and maintenance of quality improvement policies. Very strong people skills are required to develop improvement teams, and to work independently, across various disciplines. Will work with minimal supervision.

    · Coordinates the work flow of the Quality Assurance staff to ensure the efficient and timely processing of materials and information.

    · Provides advise, counsel and training to Quality Assurance staff.

    · Assembles and/or directs information for the preparation of reports.

    · Reviews generated data to ensure the suitability of the Quality System.

    · Exercises good judgment and decisions without sacrificing All-Plastics quality policy and goals.

    · Completes project assignments as assigned by the President/CEO.

    · Prepare and manages budget.

    · Participates in strategic planning.

    · Fosters team’s cooperation and development.

    · Educates personnel in the quality philosophy and practices to include improvement strategies.

    · Serves as technical support for Engineering.

    · Develops, implements and manages the Quality System requirements for ISO

    · Coordinates plans to ensure an effective flow of work between departments.

    · Reviews, observes and audits quality effecting activities.

    · Managers the Internal Audit Process.

    · Works with self-directed teams to facilitate human resource and process management.

    · Various other duties as assigned.


    Preferred: BS or BA degree preferred in an engineering, science or industrial management discipline and CQA Certified. Also prefer a minimum of 5 years management experience with demonstrated TQM, communication, interpersonal, leadership skills.

    Required: High School Diploma with a minimum of five years of relevant experience in quality or product assurance

    Required: MUST have experience with ISO 13485:2016

    Accuracy of +/- 25 Microns