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Director of Quality Assurance and Regulatory Affairs Systems

2 months ago

Warsaw, Indiana, United States Tecomet, Inc. Full time
Job Summary

We are seeking a highly experienced and skilled Director of Quality Assurance and Regulatory Affairs Systems to lead our global quality assurance and regulatory affairs systems efforts. This is a key leadership role that will be responsible for ensuring patient and employee safety, achieving customer quality requirements, and maintaining compliance with FDA and ISO regulations.

Key Responsibilities
  • Oversee and implement world-class quality systems for planning, design of experiments, ISO 13485, quality function development, and design for manufacturability.
  • Take a leadership role as a Sr. Director and mentor supporting functional team members, integrating the quality function with manufacturing as a value-added support function.
  • Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity, and maximize profit margins.
  • Assure Tecomet Medical is conducting business within compliance to regulations, as cost-effectively and efficiently as possible.
  • Provide organizational assessments to upper management.
  • Enhance the one company systems interface capabilities, optimizing harmonized systems improvements, and deploying best practices from worldwide teams.
  • Ensure quality systems focus remains on continual quality improvement, aligned with internal and external customer expectations.
  • Ensure the organization is basing improvement-related decisions on factually meaningful data, reducing waste, and expediting favorable results.
  • Leadership responsibility for promoting and developing Tecomet Medical's Environment Management System, Worldwide Quality Management Systems Software implementation/validation and harmonization, New Product Development, and Worldwide Supplier Quality Systems.
Requirements
  • Bachelor of Science in Engineering (ME, IE, BME) required.
  • Six Sigma Black Belt certification desirable but not essential.
  • Seven to ten years of quality engineering experience directly in new product development of medical devices required.
  • Master's degree desirable but not essential.