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Responsibilities :

• Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and regulatory issues (Mainly focused on support of the injection molding department).
• Maintains familiarity with manufacturing processes and products to evaluate the cause and effect of defects and identify trends in process and product quality.
• Provides technical input for projects using the application of FMEA's, risk mitigation, plant validations; DOE's' and other experiments and investigations as assigned.
• Lead projects using the application of continuous improvement tools and methodologies such as Six Sigma, Lean, etc.
• Works with all departments to maintain the highest quality standards.
• Formulates, reviews and implements policies and procedures relating to product quality and process control as appropriate.
• Ensures that all activities comply with government (OSHA, EPA, FDA, ISO, etc.) regulations and corresponding company policies/procedures including activities and programs as defined in the Quality Systems Manual for BD Broken Bow.
• Coordinates machine and process capability studies, analyzes the data and submits recommendations.
• Designs and assists Production, Engineering and Division in the completion of new product/process evaluations including Hazard Analysis.
• Coordinates communication between Division R&D and Plant personnel on new products, product improvements and product issues.
• Participates in Engineering and Production functions as required to achieve the overall objectives of the Plant.
• Performs other duties as assigned, such as Internal Audits, PIR/CFI investigations.
• Supports plant safety initiatives.
• Complies with, and responsible for enforcing, all local, state, federal and Client safety regulations, policies/procedures.
• Complies with all local Client quality policies/procedures/practices through consistent application of sound Quality Assurance principles. Ensures compliance through appropriate communication, training, and education of sound Quality Assurance principles. Responsible for the activities and programs as defined for this position in the Quality Systems Manual - Client Broken Bow.
• Performs other job-related duties as assigned.
• Observes and reinforces all safety, environmental and quality system standards.
• Controls activities within his/her scope of control, such that departmental budgets are met. Contribute information as required to establish departmental budgets.
• Is familiar with plant and divisional goals and develop standards of performance that will contribute to the accomplishments of those goals.

Requirement:

• B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent.
• Working knowledge of Validations, IQ, OQ, PQ, and DOE's is desirable.
• Working knowledge of QSR's/ISO 9000 and their application would be a plus.
• Black Belt/Six Sigma training highly desirable.
• Experience in the application of FMEA and risk mitigation.
• Experience with Value Stream Analysis and Lean Methods highly desirable.
• Proven track record of supporting and driving continuous improvement activities in a production environment.