Job Description Summary

GENERAL FUNCTION:
To assist the Manufacturing Departments in the establishment and implementation of programs designed to assure control of processes and products toward established standards of quality. To use problem solving techniques to increase quality and productivity within the Business Unit/ Department.

Job Description

RESPONSIBILITY:

• Essential responsibilities include but are not limited to:
• Develop, change and monitor in-process inspections to ensure the greatest value in quality control for the customer and the plant during the manufacturing process while meeting regulatory requirements.
• Process monitoring and adjustment, process improvement, and product improvement including corrective action plans to address complaint issues.
• Documentation of these activities along with the review and maintenance of O.I.s and department specific operating procedures such as manufacturing cleaning procedures.
• Employee training of Quality Control concerns regarding specifications.
• Develop and implement quality procedures applicable to the total plant manufacturing process for assigned product lines.
• Coordinate efforts with Process Engineering, and Production for the establishment of controls, which support current product designs, and process capabilities for assigned product lines. Assistance in such areas as process validation, process acceptance, certain audit correction actions. Manufacturing, microbiological environmental limits and PM compliance.
• Monitor the performance of assigned product lines with regard to product quality levels, waste and rejection rates.
• Leading / mentoring / conducting quality improvement projects thru continuous improvement initiatives.
• May obtain Green - Black Belt Certification
• Support in the acceptance and validation of process-equipment.
• Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality cost.
• Assume a role of leadership in analyzing and resolving issues, which prevent desired quality levels achievement.
• Develop programs for the maintenance, replacement and improvement of inspection gauging.
• Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices.
• Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements.
• Own and continue to improve department training systems.
• Monitor customer complaints and trends. Respond as needed for specific corrective action and customer interface.
• Provide assistance and guidance on quality improvement.
• Insure that all company safety rules and regulations are followed and promote general plant safety.
• Assist in internal and external audits.
• Other duties, as assigned.

Primary Work Location

USA NE - Columbus (West)

Additional Locations

Work Shift