Sr Quality Engineer

3 weeks ago


Andover, United States Katalyst HealthCares & Life Sciences Full time

Responsibilities:

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).

Actively 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.

Requirements:

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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