Quality Assurance Specialist

2 weeks ago

Atlanta, Georgia, United States CorDx Full time
Job Overview

CorDx is a global biotechnology firm dedicated to advancing innovation and supply in the realm of global health. With a workforce exceeding 2,100 across various regions, CorDx provides rapid testing and point-of-care medical device solutions for detecting infectious diseases, including COVID-19, pregnancy, substance abuse, biomarkers, and more. The organization stands at the forefront of technology, artificial intelligence, and data science, aiming to deliver diagnostic solutions to some of the most pressing challenges in healthcare.

Position Type: Full-time

Role Summary: The Quality and Health & Safety Specialist is tasked with ensuring that the company’s quality management systems and health and safety initiatives align with regulatory standards and internal policies. This position involves the implementation and oversight of quality assurance processes, conducting safety audits, and fostering a culture of safety and quality throughout the organization.

Key Responsibilities:

  • Quality Management:
    • Maintain the Quality Management System (QMS) in compliance with ISO standards and other regulatory requirements.
    • Conduct internal audits to verify adherence to QMS procedures and regulatory standards.
    • Oversee nonconformance reports and the corrective and preventive action (CAPA) processes.
    • Collaborate with cross-functional teams to ensure quality standards are upheld in production, supply chain, and product development.
    • Prepare and present quality performance metrics to management.
    • Facilitate management reviews of the QMS and promote continuous improvement initiatives.
    • Implement and uphold health and safety programs and policies in accordance with OSHA regulations and other relevant standards.
  • Regulatory Compliance:
    • Stay informed about local and industry regulations and standards related to quality and health and safety.
    • Ensure all company operations comply with applicable laws and regulations.
    • Assist in preparations for regulatory inspections and audits, ensuring timely resolution of any findings.
  • Continuous Improvement:
    • Identify opportunities for enhancements in both quality and safety processes.
    • Lead or engage in cross-functional teams to execute improvement projects.
    • Encourage a culture of continuous improvement and proactive risk management within the organization.

Qualifications:

  • Bachelor's degree in Quality Management, Occupational Health and Safety, Engineering, or a related field.
  • 3-5 years of experience in quality assurance and health and safety roles, preferably within a manufacturing or industrial setting.
  • Preferred certifications include Certified Quality Auditor (CQA), Certified Safety Professional (CSP), or similar.

Skills and Competencies:

  • In-depth knowledge of ISO 9001, ISO 45001, OSHA regulations, and other pertinent standards.
  • Experience with quality management systems and health and safety programs.
  • Strong analytical and problem-solving abilities.
  • Effective communication and interpersonal skills.
  • Capability to conduct training and presentations.

Benefits:

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

CorDx is an equal-opportunity employer that values diversity, recognizing that varied perspectives and backgrounds strengthen teams. We are committed to fostering an inclusive environment and 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.

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