Cordx
Senior QA Manager
Atlanta, Georgia, United States · Senior
Sponsorship not specifiedDetected 446 days ago
Data ScienceFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingTime ManagementMentoringRegulatory Affairs
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Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health.
- 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.
Responsibilities
- Leadership & Collaboration: Demonstrated ability to supervise and mentor QA staff, manage priorities, and effectively collaborate in a cross-functional environment.
- Strong organizational and time management skills with the ability to manage multiple projects and deadlines.
Requirements
- Regulatory Expertise: Working knowledge of FDA 21 CFR Part 820, ISO 13485, and other applicable international quality standards.
Nice to have
- Lead and support internal and external audits, supplier audits, and management reviews, including preparation of required documentation and follow-up actions.
- Oversee the management of non-conformances (NCRs), CAPAs, complaints, and deviations, ensuring timely investigations, root cause analysis, and effective corrective and preventive actions.
- Assist in the preparation for regulatory inspections and third-party audits, serving as a key member of the audit response team.
- Monitor and interpret relevant regulatory changes and industry trends, advising management on necessary updates to quality systems and processes.
- Provide training and mentorship to QA staff, fostering a culture of continuous improvement and compliance.
- Bachelor's degree in a scientific, engineering, or related technical discipline required.
- Master's degree or advanced certifications preferred.
- Minimum of 3 years in a QA leadership or management role.
Skills
- Proficient in problem-solving methodologies, root cause analysis, and quality improvement tools.
- Experience with QMS software and documentation systems is a plus.
- Certifications: ASQ certifications (such as CQE, CQA, or CMQ/OE) preferred.
- Ability to promote and sustain a culture of quality awareness, compliance, and continuous improvement.
- Highly competitive compensation package.
- Comprehensive medical, dental, and vision insurance.
- 401(k) plan with generous company contributions.
- Flexible paid time off (PTO) policy.
- Additional substantial benefits.
- Certifications:
- ASQ certifications (such as CQE, CQA, or CMQ/OE) preferred.
Benefits
- We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
Company info
- Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity.
Equal opportunity
- Statement: We are an equal opportunity employer committed to inclusion and diversity.
- Equal Opportunity Statement:
- We are an equal opportunity employer committed to inclusion and diversity.
This listing is sourced directly from Cordx's careers page and normalized into a canonical job model.