Jobs in the United States

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Added 1 min ago
Staff Systems Test Engineer, Scenario Quality and Maintenance Systems
Waymo
Mountain View, CA · San Francisco, CA
Waymo's Systems Engineering team works together to blend software and hardware systems in groundbreaking new ways. We set the high performance standards that ensure our vehicles run…
Added 12 mins ago
G
Mechanical Project Manager
GPAC
Germantown, MD
- $80,000 to $120,000 USD / year
The Project Manager is responsible for leading mechanical construction projects from preconstruction through closeout. This role requires strong leadership, financial oversight, scheduling…
Added 13 mins ago
Program Manager, Transformation Office
AVEVA Solutions
Philadelphia, PA
AVEVA is creating software trusted by over 90% of leading industrial companies.
Added 16 mins ago
Civil/Municipal Project Manager
CP Engineers
Remote, United States
The Civil/Municipal Project Manager is responsible for leading and overseeing the successful delivery of civil and municipal engineering projects, including municipal capital projects,…
Added 16 mins ago
Civil/Municipal Project Manager
CP Engineers
Remote, United States
The Civil/Municipal Project Manager is responsible for leading and overseeing the successful delivery of civil and municipal engineering projects, including municipal capital projects,…
Added 16 mins ago
Group Manager, Water Resources Engineering
CP Engineers
Remote, United States
We are seeking a Group Manager for our Water and Wastewater team with 15+ years of experience to lead the planning, design, and construction of water and wastewater infrastructure projects.…
Added 16 mins ago
Project Manager- Commercial & Industrial Services
CP Engineers
Remote, United States
As a result of our continued strategic growth, we are seeking a Project Manager to join our highly respected Commercial & Industrial Services team. This role is responsible for leading and…
Added 16 mins ago
Project Manager- Commercial & Industrial Services
CP Engineers
Remote, United States
As a result of our continued strategic growth, we are seeking a Project Manager to join our highly respected Commercial & Industrial Services team. This role is responsible for leading and…
Added 16 mins ago
Group Manager, Water Resources Engineering
CP Engineers
Remote, United States
We are seeking a Group Manager for our Water and Wastewater team with 15+ years of experience to lead the planning, design, and construction of water and wastewater infrastructure projects.…
Added 17 mins ago
Project Engineer, Transit
HNTB Corporation
Los Angeles, CA
…and modification of design calculations, technical reports, engineering plans and specifications for assigned projects. This position consults with the project manager to perform research,…
Added 28 mins ago
Structural/Bridge Project Manager
Harrison Consulting Solutions
St. Louis, MO
A civil engineering firm located in multiple locations is seeking a Structural/Bridge Project Manager for their St. Louis office!
Added 28 mins ago
Structural/Bridge Project Manager
Harrison Consulting Solutions
Effingham, IL
A civil engineering firm located in multiple locations is seeking a Structural/Bridge Project Manager for their Effingham office!
Added 33 mins ago
Senior Project Manager - Data Center Construction
GPAC
Austin, TX
Senior Construction Project Manager – Data Center Projects
Added 33 mins ago
Senior Project Manager - Data Center Construction
GPAC
St Louis, MO
Senior Construction Project Manager – Data Center Projects
Added 33 mins ago
Senior Project Manager - Data Center Construction
GPAC
Minneapolis, MN
Senior Construction Project Manager – Data Center Projects
Added 33 mins ago
Senior Project Manager - Data Center Construction
GPAC
Houston, TX
Senior Construction Project Manager – Data Center Projects
Added 35 mins ago
Project Manager
GPAC
Denver, CO
A highly respected Denver area commercial general contractor is looking to add an experienced Project Manager to its team. This is an opportunity to step into a strong local pipeline of…
Added 40 mins ago
Senior QA Manager
CorDx
Atlanta, GA
Bachelor’s degree in a scientific, engineering, or related technical discipline required.
Added 40 mins ago
Regulatory Affairs Manager - IVD
CorDx
San Diego, CA
CorDx Inc. is seeking an experienced Regulatory Affairs Manager to support the development, registration, and lifecycle management of in vitro diagnostic (IVD) medical devices in the United…
Added 40 mins ago
Senior Project Manager (Atlanta)
CorDx
Atlanta, GA
We are seeking a highly motivated and experienced Senior Project Manager to lead and support cross-functional projects within our In Vitro Diagnostics (IVD) and broader diagnostics…
Added 40 mins ago
Senior Project Manager (San Diego) - Bilingual (Mandarin Speaking)
CorDx
San Diego, CA
We are seeking a highly motivated and experienced Senior Project Manager to lead and support cross-functional projects within our In Vitro Diagnostics (IVD) and broader diagnostics…
Added 40 mins ago
Assistant Project Manager - Commercial Construction
GPAC
Fort Worth, TX
Assistant Project Manager – Commercial Construction
Added 40 mins ago
Bio Equip Support Specialist
Veterans Affairs, Veterans Health Administration
Saint Louis, MO
Added 56 mins ago
G
Traveling Federal Safety Manager
GPAC
Bismarck, ND
- $130,000 to $170,000 USD / year
…Municipal, Higher Education and public safety, is seeking a Safety Manager to oversee the safety of these…
Added 56 mins ago
G
Traveling Federal Safety Manager
GPAC
Chicago, IL
- $130,000 to $170,000 USD / year
…Municipal, Higher Education and public safety, is seeking a Safety Manager to oversee the safety of these…

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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