CorDx ยท 6 months ago
Senior QA Manager
Atlanta, GA
Full-time
Onsite
Senior Level
7+ years expCorDx is a multi-national biotech organization focused on innovation in global health, delivering rapid testing and point-of-care medical device solutions. They are seeking a Senior QA Manager to oversee the QA team, ensuring compliance with quality processes and regulatory standards while collaborating with various teams to integrate quality requirements into product development.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Manage and supervise the QA team's daily activities, ensuring timely and effective execution of quality processes
Support the implementation and maintenance of the company's QMS, ensuring ongoing compliance with FDA 21 CFR Part 820, ISO 13485, and other relevant standards
Collaborate with R&D, Manufacturing, Regulatory Affairs, and Operations teams to integrate quality requirements into product development, manufacturing, and support processes
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
Develop and track quality metrics (KPIs) to monitor the effectiveness of the QA program and identify opportunities for improvement
Provide training and mentorship to QA staff, fostering a culture of continuous improvement and compliance
Support risk management activities, including risk assessments and mitigation planning
Qualification
Required
Bachelor's degree in a scientific, engineering, or related technical discipline required
7+ years of progressive QA experience within the IVD, medical device, or regulated life sciences industry
Minimum of 3 years in a QA leadership or management role
Hands-on experience in manufacturing and product quality oversight in a regulated environment
Working knowledge of FDA 21 CFR Part 820, ISO 13485, and other applicable international quality standards
Demonstrated ability to supervise and mentor QA staff, manage priorities, and effectively collaborate in a cross-functional environment
Strong interpersonal and communication skills
Proficient in problem-solving methodologies, root cause analysis, and quality improvement tools
Preferred
Master's degree or advanced certifications preferred
Experience supporting regulatory audits, product inspections, and submissions (experience leading them preferred)
Experience with QMS software and documentation systems is a plus
ASQ certifications (such as CQE, CQA, or CMQ/OE) preferred
Strong organizational and time management skills with the ability to manage multiple projects and deadlines
Ability to promote and sustain a culture of quality awareness, compliance, and continuous improvement
Benefits
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
Company
CorDx
CorDx provides medical device solutions to the healthcare industry.
1001-5000 employees
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