CorDx
CorDx is a multinational biotech organization focused on innovation and global health. With over 2,100 employees across the world, CorDx delivers rapid testing and point-of-care diagnostic solutions used in detecting infectious diseases and other health indicators. The Quality & Health and Safety Specialist ensures 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
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
IT Services and IT Consulting
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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
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
IT Services and IT Consulting
#J-18808-Ljbffr