CorDx · 6 months ago
Quality & Health and Safety Specialist
CorDx is a multi-national biotech organization focused on innovation and supply in global health. The Quality & Health and Safety Specialist is responsible for ensuring compliance with quality management systems and health and safety programs, implementing quality assurance processes, conducting safety audits, and fostering a culture of safety and quality within the organization.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
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 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
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
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
Qualification
Required
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
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
Preferred
Certified Quality Auditor (CQA), Certified Safety Professional (CSP), or similar certifications
Benefits
Health Care Plan (Medical)
401K
Paid Time Off
Training & Development
Company
CorDx
CorDx provides medical device solutions to the healthcare industry.
H1B Sponsorship
CorDx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
Funding
Current Stage
Late StageRecent News
2025-03-26
Company data provided by crunchbase