Quality Assurance Manager

2 days ago


Elkton, Maryland, United States Saxon Global Full time
Job Title: Quality Assurance Manager

Saxon Global is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality operations team, you will be responsible for ensuring compliance with regulatory requirements and developing efficient quality systems.

Key Responsibilities:
  • Establish and promote a culture of quality excellence within the organization.
  • Develop and implement quality systems that meet regulatory requirements.
  • Manage a team of quality engineers to drive problem-solving and continuous improvement initiatives.
  • Partner with operations managers to develop and implement strategies that promote quality culture throughout the organization.
  • Ensure compliance with regulatory requirements, including ISO 13485 and MDR.
Qualifications:
  • Bachelor's degree in science or mathematics.
  • Minimum 10-15 years of quality assurance experience.
  • Minimum 5-8 years of management experience.
  • Six Sigma/LEAN experience preferred.
Knowledge, Skills, and Abilities:
  • Knowledge of national and international regulations applicable to medical devices.
  • Ability to analyze and interpret regulatory guidelines.
  • Strong understanding of quality sciences, including acceptance sampling, SPC, and continual improvement.


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