Browse
···
Log in / Register

Senior QA Manager

Negotiable Salary

CorDx

Atlanta, GA, USA

Favourites
Share

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. Requirements 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. 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. 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. 

Source:  workable View original post

Location
Atlanta, GA, USA
Show map

workable

You may also like

Workable
ADA Tester
Experience: 5 Years Duties and Responsibilities As a Web Accessibility Specialist, you will lead all testing and audit activities using manual and automated accessibility testing tools and assistive technologies. Conduct accessibility testing using a combination of automated tools and manual testing (including testing with assistive technologies) to evaluate the level of conformance to the Web Content Accessibility Guidelines (WCAG) and other applicable standards and regulatory requirements. Create, document, and manage test plans, testcases, and scripts across multiple projects based on software requirements and design documents. Conduct functional, end-to-end, and regression testing of applications to ensure functionality, reliability, and quality. Create and maintain test scripts, standards, guidelines, and playbooks for accessibility testing and development best practices. Document and report defects, issues, and areas of improvement as well as manage and prioritize critical ADA defects. Collaborate with Business Analysts and Clients to understand requirements and provide feedback. Act as a subject matter expert for testing web and mobile applications for accessibility. Participate in system designs, Support, and foster usability testing and research for accessibility. Provide ad-hoc, project-based team training for ADA awareness, implement solutions, and foster innovation through accessibility. Preferred Qualifications: ·Bachelor’s degree in computer science, IT, MIS,Engineering, or related fields. ·7+ years of experience as a Quality Analyst withdemonstrated knowledge of quality assurance methodology and practices. ·        Hands-on experience with automated test tools and test management tools like Jira or GitLab. ·        In-depth, working knowledge of ADA tools and standards for accessibility testing (i.e., WAVE, JAWS, axe, ANDI, and other automated tools or applications). ·        5+ years of experience in User Acceptance Testing (UAT) methodologies to ensure digital products adhere to enterprise conformance levels (WCAG 2.0, 2.1 level AA) within agile projects. ·        Ability to provide solutions for testers and development teams by applying best practices. Ability to provide direction and lead QA testers. ·        Ability to effectively utilize assistive technologies such as JAWS, NVDA, Voiceover, TalkBack, and other manual and automated testing tools across multiple devices, browsers, and operating systems. ·        Certified Professional in Web Accessibility (CPWA) or Web Accessibility Specialist (WAS) certification. ·        Working knowledge of HTML5 and CSS.
Atlanta, GA, USA
Negotiable Salary
Cookie
Cookie Settings
Our Apps
Download
Download on the
APP Store
Download
Get it on
Google Play
© 2025 Servanan International Pte. Ltd.