Quality 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  

Job Title: Quality Specialist

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.
• Implement and maintain health and safety programs and policies in compliance with OSHA regulations and other relevant standard

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.

Requirements

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

Skills and Competencies:

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

Benefits

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

We are an equal-opportunity employer and celebrate 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.