QA Director

Who isCorDx?

CorDxa multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries,CorDxdelivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more.CorDxis at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Position: QA Director

Location: Atlanta, GA

Position Type: 5 days Onsite Exempt Position

• Develop and implement quality assurance strategies to ensure compliance with FDA, ISO 13485, and other relevant regulatory requirements.
• Lead and mentor the quality assurance team, fostering a culture of continuous improvement and accountability.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, 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.
• Ensure all quality-related processes and documentation are in compliance with regulatory requirements and industry best practices.
• Conduct regular audits and inspections to ensure compliance and identify areas for improvement.
• Serve as the primary point of contact for regulatory agencies and notified bodies.
• Manage the preparation and submission of regulatory filings, including 510(k) submissions, Technical Files, and PMA applications.
• Monitor and interpret regulatory changes and trends, ensuring the company remains compliant and proactive in addressing new requirements.
• Develop and implement risk management strategies, including risk assessments and mitigation plans, to ensure product safety and effectiveness.
• Lead investigations into quality issues, non-conformances, and customer complaints, implementing corrective and preventive actions as necessary.
• Establish and monitor key performance indicators (KPIs) to assess the effectiveness of the quality assurance program.
• Prepare and present regular reports to senior management on quality performance, compliance status, and improvement initiatives.
• Develop and deliver training programs to ensure all employees understand and comply with quality standards and regulatory requirements.
• Promote a culture of quality awareness and continuous improvement throughout the organization.

Requirements

Education:

• Master's degree in a scientific, engineering, or related discipline required; advanced degrees preferred.

Professional Experience:

• 10+ years of progressive quality assurance experience within the IVD Class II medical device industry.
• Proven experience successfully leading and managing QA teams in a highly regulated manufacturing environment.

Regulatory Expertise:

• Extensive, hands-on knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other global quality standards.
• Experience preparing for and managing regulatory inspections, audits, and product submissions.

Leadership & Collaboration:

• Strong track record of building and developing high-performing QA teams.
• Excellent interpersonal and communication skills, with the ability to lead cross-functional teams and influence at all organizational levels.

Technical & Analytical Skills:

• Strong analytical, problem-solving, and decision-making abilities in a fast-paced, regulated environment.

Certifications:

• ASQ certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) highly desirable.

Preferred Attributes:

• Demonstrated ability to implement continuous improvement initiatives and maintain a culture of quality excellence.
• Experience working with global teams and international regulatory requirements is a plus.

Benefits

• Highly competitive compensation package.
• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with generous company contributions.
• Flexible paid time off (PTO) policy.
• Additional substantial benefits.

Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Qualification

Bachelor's Degree