Worldwide Quality Assurance and Regulatory Affairs Systems Leader

1 week ago


Massachusetts, United States Tecomet, Inc Full time
Job Title: Worldwide Quality Assurance and Regulatory Affairs Systems Leader

Tecomet, a leading global provider of innovative solutions for the medical device industry, is seeking an experienced leader to oversee its worldwide Quality Assurance and Regulatory Affairs Systems.

Job Summary:

As a key member of our leadership team, you will be responsible for providing strategic direction and leadership to our global quality assurance and regulatory affairs teams. Your primary objective will be to ensure patient and employee safety, while achieving customer quality requirements and maintaining compliance with FDA and ISO regulations.

Key Responsibilities:
  • Develop and Implement World-Class Quality Systems:
    • Design and implement advanced quality systems for planning, design of experiments (DOE), ISO 13485, quality function development (QFD), and design for manufacturability.
    • Lead the development of quality systems that facilitate good products fast without compromise.
  • Ensure Compliance and Efficiency:
    • Assure Tecomet Medical is conducting business within compliance to regulations, while minimizing costs and maximizing efficiency.
    • Enhance the one company systems interface capabilities to perpetuate harmonized systems improvements.
  • Drive Continuous Improvement:
    • Ensure the quality systems focus remains on continual quality improvement, aligned with internal and external customer expectations.
    • Develop and implement systems that deliver products on time with world-class quality standards.
  • Lead Cross-Functional Teams:
    • Lead the development of quality systems that integrate with manufacturing as a value-added support function.
    • Collaborate with cross-functional teams to optimize the continuous quality improvement process.
Requirements:
  • Bachelor of Science in Engineering (ME, IE, BME) required.
  • Seven to ten years of quality engineering experience directly in new product development of medical devices required.
  • Six Sigma Black Belt certification desirable but not essential.
  • Master's degree desirable but not essential.


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