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- Implement, manage, and improve the company's quality management system, with a primary focus on IVD products and equipment
- Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA)
- Lead and participate in internal audits and management reviews of the company's quality system as a key member of the quality department
- Manage the documentation of the company's quality management system, ensuring compliance with relevant standards and regulations
- Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards
- Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed
- Update company documents in accordance with new or revised quality standards, laws, and regulations
- Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements
- Minimum Bachelor's degree in Science or related field
- ISO 13485:2016 lead auditor certification preferred
- Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards
- Strong understanding of quality management principles and practices in the medical device industry
- Excellent communication and interpersonal skills
- Ability to work collaboratively in a team environment
- Demonstrated problem-solving and analytical skills
- Attention to detail and strong organizational skills
- Health Care Plan (Medical)
- 401K
- Paid Time Off
- Training & Development
Quality Manager - Atlanta, United States - CorDx
Description
We are seeking an experienced Quality Manager to join our team in the IVD (In Vitro Diagnostic) industry. The ideal candidate will have a minimum of 10 years of relevant experience in the medical device manufacturing sector, with a strong background in quality management systems, regulatory compliance, and ISO standards. The Quality Manager will play a critical role in implementing, managing, and improving our company's quality management system, with a focus on IVD products and equipment.Key Responsibilities: