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Quality Assurance Manager

2 months ago

Atlanta Georgia, United States CorDx Full time
About CorDx:

CorDx is a global biotechnology firm dedicated to advancing innovation and supply in the realm of global health.

With a workforce exceeding 2,100 professionals worldwide, we cater to millions of users across more than 100 countries, providing rapid testing and point-of-care medical device solutions for the detection of infectious diseases, including COVID-19, pregnancy, substance abuse, biomarkers, and beyond.

At CorDx, we are at the forefront of technology, artificial intelligence, and data science, striving to deliver diagnostic solutions to some of the most pressing challenges in healthcare.


Position Overview:
We are in search of a seasoned Quality Assurance Manager to become a vital part of our team within the In Vitro Diagnostic (IVD) sector.

The ideal candidate will possess a minimum of 10 years of pertinent experience in the medical device manufacturing industry, showcasing a robust background in quality management systems, regulatory adherence, and ISO standards.

The Quality Assurance Manager will be instrumental in executing, overseeing, and enhancing our organization's quality management system, particularly concerning IVD products and apparatus.


Key Responsibilities:
  • Execute, oversee, and enhance the organization's quality management system, with a primary emphasis on IVD products and apparatus.
  • Conduct internal audits, compile audit documentation, perform problem analysis, propose enhancement initiatives, and monitor the execution of corrective and preventive actions (CAPA).
  • Lead and engage in internal audits and management evaluations of the quality system as a key contributor within the quality department.
  • Manage the documentation of the quality management system, ensuring compliance with relevant standards and regulations.
  • Oversee the quality management system for IVD apparatus, ensuring adherence to applicable regulations and standards.
  • Perform statistical evaluations of IVD apparatus quality data, prepare reports, and develop corrective and preventive measures as necessary.
  • Update organizational documents in line with new or revised quality standards, laws, and regulations.
  • Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements.

Qualifications:
  • Minimum Bachelor's degree in Science or a related field.
  • ISO 13485:2016 lead auditor certification is preferred.
  • Comprehensive knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards.
  • Strong understanding of quality management principles and practices within the medical device sector.
  • Exceptional communication and interpersonal abilities.
  • Capability to work collaboratively in a team-oriented environment.
  • Demonstrated problem-solving and analytical skills.
  • Attention to detail and robust organizational skills.
  • Minimum of 10 years of experience in medical devices, quality management, regulatory compliance, and ISO standards.

Benefits:
  • Health Care Plan (Medical)
  • 401K
  • Paid Time Off
  • Training & Development

CorDx is an equal-opportunity employer that celebrates diversity, recognizing that a variety of perspectives and backgrounds strengthens our teams. We are committed to diversity and inclusion, ensuring a thoughtful approach to these principles.

We do not discriminate based on race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.