Quality Assurance Director

6 days ago


San Diego, California, United States CorDx Full time
Job Summary

We are seeking a highly experienced Quality Manager to join our team at CorDx in San Diego. This is an onsite position with a competitive salary range of $100,000- $130,000.

The ideal candidate will have a minimum of 10 years of experience in the medical device industry, with a strong background in quality management, regulatory compliance, and ISO standards.

About the Role
  • Develop and implement effective quality control processes to ensure products meet customer requirements and legal standards.
  • Devise and review specifications for products or processes, setting requirements for raw materials and monitoring supplier compliance.
  • Supervise inspectors, technicians, and other staff, providing guidance and feedback to maintain high-quality standards.
  • Oversee product development procedures to identify deviations from quality standards and inspect final output for adherence to requirements.
  • Approve products that meet standards and reject defectives, maintaining accurate documentation and performing statistical analysis.
Required Skills and Qualifications
  • Minimum Bachelor's degree in Science or related field.
  • ISO 13485:2016 lead auditor certification preferred.
  • Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards.
  • Strong understanding of quality management principles and practices in the medical device industry.
  • Excellent communication and interpersonal skills, with ability to work collaboratively in a team environment.
Benefits
  • Medical Insurance Plan
  • Retirement Plan
  • Paid Time Off
  • Training & Development
Diversity and Inclusion

We celebrate diversity and recognize that it builds stronger teams. We approach diversity and inclusion seriously and thoughtfully, ensuring a welcoming and inclusive work environment for all employees.



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