Quality Assurance Lead

3 days ago


San Diego, California, United States CorDx Full time

CorDx, a global biotech leader, seeks a Quality Assurance Lead to spearhead our quality initiatives. This role is critical in ensuring compliance with FDA and ISO 13485 regulations, as well as fostering a culture of continuous improvement within the organization.

The ideal candidate will have at least 10 years of experience in quality assurance, preferably within the IVD Class II devices manufacturing industry. A master's degree in a scientific or engineering discipline is preferred. The salary for this position is estimated to be between $120,000 and $170,000 per year, commensurate with experience.

This role involves leading the quality assurance team, developing and implementing quality strategies, and collaborating with cross-functional teams to ensure quality integration into all aspects of product development and lifecycle management. The successful candidate will also oversee the maintenance and continuous improvement of the company's QMS, ensuring all quality-related processes and documentation are compliant with regulatory requirements and industry best practices.



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