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Added 1 min ago
Program Manager, Transformation Office
AVEVA Solutions
Philadelphia, PA
Job Title: Program Manager, Tranformation Office
Added 16 mins ago
Sr. Technical Program Manager
Sony Interactive Entertainment (SIE)
Madison, WI
As a Senior Technical Program Manager, you will lead the delivery of complex software programs across Commerce Services & Client Experiences within the PlayStation ecosystem. Working…
Added 28 mins ago
Senior Manager Manufacturing - Engineering
Twenty-Six Defense
Fort Worth, TX
Job Summary: The Senior Manager Manufacturing Engineering manage and support complex defense, avionics or medical device-related manufacturing engineering activities. Lead a team of…
Added 28 mins ago
Senior QA Manager
CorDx
Atlanta, GA
Bachelor’s degree in a scientific, engineering, or related technical discipline required.
Added 29 mins ago
EC
Commercial Engineer and Codes & Standards Manager
Eaton Corporation
Ellisville, MO
- $146,000 to $215,000 USD / year
The primary function of the Commercial Engineering and Codes & Standards Manager is to lead Bussmann's customer-facing technical organization and its codes & standards agenda: winning…
Added 29 mins ago
Bio Equip Support Specialist
Veterans Affairs, Veterans Health Administration
Saint Louis, MO
Added 56 mins ago
Principal Quality Engineer
Twenty-Six Defense
Fort Worth, TX
…where the incumbent must possess an advanced level of quality engineering knowledge. Tasks at this level fall in areas where technical requirements are substantially complex. The Principal…
Added 1 hour ago
Construction Surveillance Technician Team Lead ( CSTTL )
Continuity Global Solutions
Washington, DC
Implement orders and special instructions from the Site Security Manager (SSM) and Regional Security Officer (RSO).
Added 1 hour ago
AS
Acquisition Logistics Manager Journeyman
Andromeda Systems Incorporated
Jacksonville, FL
- $28 to $47.5 USD / hour
Prepare reports, briefings, schedules, estimates, and recommendations for logistics reviews, program reviews, and technical meetings
Added 1 hour ago
Program Manager - Alexandria, VA
Military Spouse Jobs & VetJobs
United States
Akima Data Management is seeking a highly qualified Program Manager to lead a multidisciplinary team supporting mission-critical cybersecurity, information technology, and operational…
Added 1 hour ago
Assistant Superintendent
Consigli Construction
New Brunswick, NJ
Help administer project safety program to maintain a safe and healthy work environment.
Added 1 hour ago
Assistant Superintendent
Consigli Construction
NY · New York, NY
Help administer project safety program to maintain a safe and healthy work environment.
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Hamilton, NY
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Lewiston, ME
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Manchester, NH
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Pleasant Valley, NY
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Washington, DC
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Providence, RI
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Orono, ME
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
NY · New York, NY
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Albany, NY
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Milford, MA
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
CC
Field Operations Intern (Summer 2027)
Consigli Construction
Portland, ME
- $24 to $29 USD / hour
The Field Operations Intern supports Superintendents and Project Managers by assisting with safety program administration, quantity tracking, schedule analysis, and job site documentation.…
Added 1 hour ago
Senior Project Superintendent (Traveling)
Consigli Construction
St. Louis, MO
Reporting to the General Superintendent, the Senior Project Superintendent provides overall administrative and technical management of the construction project. The Senior Superintendent…
Added 1 hour ago
Senior Project Superintendent (Traveling)
Consigli Construction
Saratoga Springs, NY
Reporting to the General Superintendent, the Senior Project Superintendent provides overall administrative and technical management of the construction project. The Senior Superintendent…

CorDx

Senior QA Manager

Atlanta, GA, United States

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Job details

Education: Bachelor’s degree
Experience: 7+ years of progressive QA experience within the IVD, medical device, or regulated life sciences industry.
Posting language: English
Posted: May 12, 2025

Original job description

Who is CorDx？

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. 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.

Position: Senior QA Manager Location: Atlanta, GA Position Type: 5 days Onsite Exempt Position

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.

Education:

Bachelor’s degree in a scientific, engineering, or related technical discipline required.
Master’s degree or advanced certifications preferred.

Professional Experience:

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.

Regulatory Expertise:

Working knowledge of FDA 21 CFR Part 820, ISO 13485, and other applicable international quality standards.
Experience supporting regulatory audits, product inspections, and submissions (experience leading them preferred).

Leadership & Collaboration:

Demonstrated ability to supervise and mentor QA staff, manage priorities, and effectively collaborate in a cross-functional environment.
Strong interpersonal and communication skills.

Technical & Analytical 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.

Preferred Attributes:

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.
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.

Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. 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.

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More about this job

Skills

Regulatory compliance
Regulatory affairs
Documentation
Root cause analysis
Inspection
Quality control systems
Provide training
Process improvement
Risk management
Leadership
Collaboration
Communication skills
Analytical skills
Problem solving
Time management

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