- Lead problem solving teams for customer concerns and process improvement.
- Lead the translation of customer expectations into plant processes and inspection techniques.
- Lead cross functional teams for the timely and effective resolution of customer complaints by structured problem-solving processes (i.e., 8D).
- ctively plan training programs for self to increase core quality competencies and improve personal competencies as required by the function (i.e., facilitation skills, etc.).
- Support the confirmation of effective processes by auditing processes as required.
- Train team members in quality systems and procedures, quality tools and systems in production including SPC and non-conforming material handling.
- Maintain a standardized Quality Operating System that incorporates best practices while managing teams of Quality Engineers and QOSC's.
- Medical Quality Teams activity in the areas of team structure, problem-solving methodology (including 8D and DMAIC), and assure Statistical Process Control tools are utilized throughout the plant that comply with standards.
- Promote a zero-loss mindset and help manufacturing achieve targeted "First Time Through " and Uptime.
- Develop, implement, manage and integrate a QMS for manufacturing plants.
- Support team members in their functions and duties to ensure the production floor is fully supported regarding its quality needs.
- Serve as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement.
- Establish and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.
- Perform root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements
- Other duties as assigned.
- 7 to 10 years of experience in QA systems implementation and management in manufacturing environment.
- Must have Medical Industry experience
- Broad knowledge of theory and principles of statistics and statistical process control.
- Bachelor's degree Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or equivalent number of years of experience.
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Sr Quality Engineer - Andover, United States - Katalyst Healthcares and Life Sciences
