Quality & Health And Safety Specialist
CorDx a 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, CorDx delivers 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. CorDx is 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.
Job Type : Full time
Location : Onsite - Atlanta Office
Role Summary : The Quality & Health and Safety Specialist is responsible for ensuring that the company's quality management systems and health and safety programs comply with regulatory standards and internal policies. This role involves implementing and monitoring quality assurance processes, conducting safety audits, and promoting a culture of safety and quality throughout the organization
Key Responsibilities
Quality Management :
- Maintain the Quality Management System (QMS) in accordance with ISO standards and other regulatory requirements.
- Conduct internal audits to ensure compliance with QMS procedures and regulatory standards.
- Manage nonconformance reports and corrective and preventive action (CAPA) processes.
- Coordinate with cross-functional teams to ensure quality standards are met in production, supply chain, and product development.
- Prepare and present quality performance metrics to management.
- Facilitate management reviews of the QMS and drive continuous improvement initiatives.
Health and Safety :
Implement and maintain health and safety programs and policies in compliance with OSHA regulations and other relevant standards.Conduct regular safety inspections and audits to identify and mitigate risks.Investigate accidents, incidents, and near-misses; document findings and implement corrective actions.Provide safety training and education to employees, including new hire orientation and ongoing safety awareness programs.Maintain accurate records of safety incidents, training, and compliance activities.Coordinate emergency response plans and drills.Regulatory Compliance :
Stay up to date with local and industry regulations and standards related to quality and health and safety.Ensure all company activities and operations comply with applicable laws and regulations.Assist in preparing for regulatory inspections and audits and ensure timely resolution of any findings.Continuous Improvement :
Identify opportunities for process improvements in both quality and safety areas.Lead or participate in cross-functional teams to implement improvement projects.Promote a culture of continuous improvement and proactive risk management within the organization.