Quality Assurance Director

7 days ago

Alpharetta GA USA, United States CorDx Full time
Job Title: Quality Assurance Director

CorDx is seeking an experienced Quality Assurance Director to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices.

Key Responsibilities:
  • 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:
  • Master's degree in a scientific or engineering discipline; advanced degree preferred.
  • Minimum of 10 years of experience in quality assurance within the IVD Class II devices manufacturing industry.
  • Extensive knowledge of FDA regulations, ISO 13485, and other relevant standards.
  • Proven track record of successfully managing a quality assurance team in a regulated environment.
  • Strong analytical, problem-solving, and decision-making skills.
  • Excellent communication and interpersonal skills, with the ability to influence and lead cross-functional teams.
  • Certification in quality management (e.g., ASQ CQE, CQA) is a plus.
Benefits:
  • Medical Insurance Plan
  • Retirement Plan
  • Paid Time Off
  • Training & Development

CorDx is an equal-opportunity employer and celebrates diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of 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.

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