Has primary responsibility for development and maintenance of production quality standards and documentation.Collaborates on continuous improvement activities through problem prevention and mitigation, leads corrective actions through data analysis trending, and support external audits and the internal audit program.This includes but is not limited to support of defining quality requirements for new products and preparing/maintaining necessary documentation, monitor production quality performance to identify opportunities for improvement, complete, review and maintain quality records for compliance to creation’s quality system, as well as support customer and regulatory compliance requirements. Supports quality inspections and audit preparation. Supports customers under close supervision. Manages specific customers/serves as the quality representative within an assigned customer focus team or designated functional area.
DUTIES AND RESPONSIBILITIES include, but not limited to:
• Demonstrated ability to solve practical problems and make logical decisions.
• Participate in root-cause analysis and timely and effective resolution of Corrective Action/Preventive Action (CAPA).
• Ability to collaborate on moderate to moderately complex problems, collect appropriate data, establish facts and input into valid conclusions.
• Handles routine tasks and simple investigations with guidance.
• This role is critical to prevent repeat problem solutions and continual process improvement.
• Serve as the Quality Representative within an assigned Customer Focus Team or designated functional area.
• Interacts with other Engineers, Technicians and Production Team Members and external partners to collaborate on solutions and to execute on quality processes and standards to consistently meet the goals of customers and the organization.
• Participate in internal Quality and customer meetings.
• Works closely with Customer Focus Team members directly supporting and interacting with customers.
• Capable of communicating moderate to moderately complex problems and solutions to internal and external stakeholders in
a clear and concise manner.
• Travel as required
• Other duties and responsibilities as assigned