Quality Assurance Leadership Role in Medical Devices

7 days ago


San Diego, California, United States CorDx Full time

CorDx is a leading biotech organization focused on delivering innovative solutions for global health. We are seeking an experienced QA Director to lead our quality assurance efforts and ensure compliance with regulatory requirements.

We offer a competitive salary range of $120,000-$170,000 and a comprehensive benefits package, including medical insurance, retirement plan, and paid time off.

The successful candidate will have a Master's degree in a scientific or engineering discipline and at least 10 years of experience in quality assurance within the IVD Class II devices manufacturing industry. They will be responsible for developing and implementing quality assurance strategies, leading a team of quality professionals, and ensuring compliance with FDA regulations, ISO 13485, and other relevant standards.

In this role, you will collaborate with cross-functional teams to integrate quality into all aspects of product development and lifecycle management. You will also oversee the maintenance and continuous improvement of our Quality Management System (QMS) and ensure that all quality-related processes and documentation are in compliance with regulatory requirements and industry best practices.

We value diversity and inclusion and are committed to creating a workplace where everyone feels welcome and valued. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.

  • Key Responsibilities:
  • Develop and implement quality assurance strategies to ensure compliance with regulatory requirements
  • Lead and mentor the quality assurance team
  • Collaborate with cross-functional teams to ensure quality is integrated into all aspects of product development and lifecycle management
  • Oversee the maintenance and continuous improvement of the company's QMS


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