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Director of Quality Systems

1 month ago

Scottsdale, Arizona, United States Innovative Health LLC Full time
Job Summary

The Director of Quality Systems will lead the establishment and maintenance of a Quality System that meets FDA and ISO requirements, while ensuring customer satisfaction and positively impacting the company's financial performance.

Key Responsibilities:

  • Develop and implement quality policies and procedures to ensure compliance with regulatory requirements;
  • Oversee CAPA processes, internal and supplier audits, customer complaints, documentation, and training;
  • Initiate and implement quality improvement activities to raise the performance of the company's product lines;
  • Provide quality leadership to all levels of the organization;
  • Lead internal audits and support external audits, including ISO certification;
  • Perform root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements;
  • Establish collection and analysis systems of statistical data to predict trends that will affect improvement of product quality;
  • Responsible for document control/change control and training activities;
  • Develop and implement strategies for international certifications and licenses;
  • Manage Quality personnel daily;
  • Design, implement, and document procedures for process control, process improvement, testing, and inspection;
  • Establish and implement metrics for monitoring system effectiveness and to enable managers to make sound product quality decisions;
  • Reports to management on quality issues, trends, and losses;
  • All other duties as assigned.

Requirements:

  • Bachelor's degree in mechanical engineering, electrical engineering, manufacturing engineering, or business administration, or equivalent number of years of experience;
  • Fifteen (15) years of experience in Quality, including ten (10) years of managing personnel;
  • Experience working with FDA and audit preparedness;
  • Regulatory Affairs background is preferred;
  • Experience working in the medical device industry is a must;
  • Experience with 21CFR820, Quality Systems Regulation, and ISO 13485 is a must.