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
Senior QA Analyst
Staff4Me is currently seeking a highly experienced and proactive Senior QA Analyst to join our team. As a Senior QA Analyst, you will be responsible for ensuring the quality of our software products through rigorous testing and careful analysis. You will work closely with the development team to identify, document, and track defects, as well as contribute to the overall improvement of our QA processes. Responsibilities Design, develop, and execute comprehensive test plans and test cases. Perform functional, regression, and performance testing to identify and report software defects. Conduct thorough root cause analysis of defects and collaborate with the development team to ensure timely resolution. Create detailed test documentation, including test scripts, test data, and test reports. Perform risk analysis and prioritize testing efforts based on the impact and probability of defects. Participate in design and code reviews to provide constructive feedback. Collaborate with cross-functional teams to ensure quality standards are met throughout the software development lifecycle. Stay updated with the latest testing methodologies and industry best practices. Mentor and provide guidance to junior QA team members. Requirements 5+ years of experience as a QA Analyst, with a focus on software testing. Strong knowledge of software QA methodologies, tools, and processes. Experience in designing and executing test plans, test cases, and test scripts. Proficiency in using test management and defect tracking tools. Solid understanding of test automation frameworks and scripting languages. Excellent analytical and problem-solving skills. Ability to effectively communicate and collaborate with cross-functional teams. Experience in Agile or Scrum development methodologies. Relevant certifications such as ISTQB or CSTE are a plus. Bachelor's degree in Computer Science, Engineering, or a related field.
New York, NY, USA
Negotiable Salary
Craigslist
Database Technician (Palmer)
POSITION SUMMARY: The Database Technician supports Tribal participation in major infrastructure projects by overseeing database management, project coordination, and financial tracking under the supervision of the Project Manager. This role ensures accurate data integration for regulatory compliance, environmental review, and engineering assessments while maintaining financial records, procurement oversight, and logistical support. DUTIES AND RESPONSIBILITIES The successful candidate will: • Maintain GIS databases, environmental records, and regulatory documentation while ensuring the accuracy, security, and accessibility of project-related data. • Provide administrative support for final presentations and compiling and submitting reports to federal, state, and Tribal partners. • Track cultural resource impact assessments to support preservation efforts. • Work alongside the Project Manager to ensure alignment between field operations and administrative workflows. • Coordinate daily database operations with the Tribal Civil Engineer and Natural Resources Department Director. • Provide logistical support to engineering review teams, environmental monitors, and cultural resource specialists. • Assist in processing timesheets, staffing requests, and equipment mobilization as part of the Tribal team’s participation in the project. • Monitor funding allocations, ensuring Tribal participation remains cost-effective and compliant. • Prepare financial summaries and expenditure reports for leadership review. • Assist with grant administration, procurement approvals, and budget forecasting for preconstruction and construction phases. • Maintain contract agreements and financial records aligned with DOT & PF and Tribal financial requirements. • Ensure all regulatory filings, permits, and compliance documentation are properly maintained. • Assist Tribal Civil Engineer and Project Manager in reviewing engineering plans, geotechnical data, and cultural resource findings. • Contribute to weekly and bi-weekly Tribal team meetings, assisting in progress tracking and interagency coordination. JOB SPECIFICATIONS: • Ability to collect data, establish facts, define problems, and draw valid conclusions. • Provide outstanding customer service to external and internal customers. • Demonstrated proficiency with Microsoft Project, Primavera P6, GIS-based data processing, and cloud database systems for regulatory documentation. • Strong knowledge of budget forecasting, grant administration, and procurement tracking for large scale infrastructure projects. • Ability to work well and with a high degree of accuracy in a busy office environment with frequent interruptions and changing priorities. • Excellent verbal and written communication skills. • Strong technical and organizational skills. • Demonstrated ability to manage multiple projects, priorities, and relationships. • Ability to work independently and interdependently in a positive and productive manner. • Ability to make decisions and exercise good judgement. • Ability to work outdoors in various weather conditions. • Maintain confidentiality and securing sensitive information. • Willingness to learn new skills and be a team player. MINIMUM REQUIREMENTS: • Bachelor’s degree in Business Administration, Information Systems, Project Management, or related field. • Five (5) + years of experience in database management, project oversight, and financial tracking; Or any equivalent combination of experience and training which provides the required knowledge, skill, and abilities. • Ability to manage high-volume data processing and secure documentation protocols. • Must have a valid driver’s license and good driving record. • Clean state and federal background check. CONDITIONS OF EMPLOYMENT: • Knowledge and experience of Knik Tribe’s Service Area and Knik Tribe’s Programs. • Adequate understanding of all Microsoft Office Applications. • Capable of basic maintenance for general office equipment and multi-line phone systems. • Must pass a criminal background check and be free of barrier crimes. • Clean driving record. • Knowledge and application of professional and ethical conduct as guided by Knik Tribal Council Personnel Manual Section 8.1. ADDITIONAL INFORMATION: NATIVE PREFERENCE STATEMENT: Pursuant to the Indian Self-Determination and Education Assistance Act of 1975 (PL 93-638) and as further guided by Knik Tribe Native Preference Policy 6.120, Knik Tribe maintains preference in all phases of employment for Alaska Native, American Indian (AN/AI) and Native Hawaiian people, including direct lineal descendants and foster or traditionally adopted children. Also included are non-Native head of household member of Native families, which includes foster or traditionally adopted Native children. DETAILS OF EMPLOYMENT: • Location : 1800 N Laurel Dr, Palmer, AK 99645 and project site • Supervisor: Project Manager • Schedule: Monday – Friday. 8:00 a.m. – 5:00 p.m. Full-time (40 hrs/week), three-year position. • Salary: $31.41 per hour. Plus full benefits: Federal Employee Health Benefits (FEHB) medical, dental, vision, life insurance, paid leave and holidays, and retirement plan with matching contributions. To Apply: Submit Resume to: Human Resources at hr@kniktribe.org For more information or to download the job description visit www.kniktribe.org/careers
J2J7+44 Lazy Mountain, AK, USA
$31/hour
Craigslist
Prepress Technician/Mac Operator (Denver)
Job Summary: Highly motivated individual with a minimum of 3 years’ experience in a high-volume prepress environment for Web Offset and Digital presses. Essential Job Functions: • Preflight/edit/troubleshoot customer files to ensure they conform to a job’s specification. • Process/trap files in Kodak Prinergy. • Provide detailed analysis of potential problems and/or showstoppers to Account Management. • Impose files for proof and/or press using Kodak Preps. • Output (RIP) files for correct proof and/or plate manufacturing. • Perform quality assurance throughout the prepress production cycle. • Performs other duties and special tasks when assigned. Qualifications: • Understanding of current Prepress and Print Industry standards and expectations. • Knowledge of Mac and applied software • Fundamental knowledge of ripping and trapping of files. • Demonstrate ability to read and comprehend written instructions. • Excellent interpersonal, problem solving and troubleshooting skills with a keen attention to detail. • Good communication, organizational and time management skills. • Adobe Creative Cloud; Acrobat, InDesign, Illustrator, Photoshop. • Enfocus PitStop Pro • QuarkXPress • Kodak Prinergy Connect (Workshop) • Preps Imposition software Physical Demands: • The physical demands are typical for an office setting. Must be able to lift up to 20 pounds. Apply here: https://recruiting.paylocity.com/recruiting/jobs/Apply/3634285/Publication-Printers-Corporation/Mac-Operator
2001 S Platte River Dr, Denver, CO 80223, USA
$25-30/hour
Workable
UAT Lead
Position Overview: The UAT Lead will oversee the User Acceptance Testing (UAT) efforts for Georgia Access, ensuring that the Eligibility and Enrollment System, Consumer Portal, Agent Portal, EDE partners, partner integration items which are relevant and website function as expected. The role requires a blend of technical expertise, project management experience, and stakeholder coordination to manage test planning, execution, defect tracking, and release readiness.The UAT Lead will collaborate with business stakeholders, technology vendors, and cross-functional teams to drive a successful testing lifecycle, ensuring compliance with federal and state regulations to drive UAT Success. The candidate will be responsible for writing the scenarios for the requirements, derive the test cases, review the test cases with the business and stake holders, handle the environment readiness, Entry and Exit criteria presentations and review with the stake holders. Ask the relevant questions. Bring new processes to streamline and ensure the team follows the strategy, capture lessons learned with few metrics to baseline the quality. Local candidates only as they will be required to work onsite 3 days per week.  Key Responsibilities UAT Strategy & Planning • Develop and implement comprehensive UAT strategies aligned with business requirements and regulatory compliance. • Define and enforce UAT entry and exit criteria, ensuring alignment with quality standards.   Create and manage test plans, scenarios, and test cases in collaboration with business analysts, developers, and end users.   Execution & Oversight •  Lead and coordinate UAT execution across multiple workstreams, ensuring timely completion. •  Oversee test execution performed by vendors and internal teams, ensuring traceability and defect resolution. •  Implement test automation strategies to improve efficiency and reduce manual effort. •  Participate in defect triage discussions and drive resolution in coordination with developers, system architects, and business owners. • Perform risk-based testing and impact analysis to ensure comprehensive test coverage. • Lead data validation and integration testing across multiple systems, ensuring accuracy and consistency. • Knowledge on performance and load testing coordination with technology/EDE partners. help define high-traffic test scenarios and review results. • Coordinating defect resolution across internal and external teams to ensure compliance-driven fixes • Should ensure accurate eligibility determination and system-to-system reconciliation.    Stakeholder Management & Reporting • Work closely with business, IT, policy, and vendor teams to facilitate testing activities and address blockers. • Communicate UAT progress, risks, and issues to senior leadership through dashboards and reports. • Conduct weekly status meetings, risk assessments, and post-mortem analysis for continuous improvement. • Collaborate with the Release Management team to ensure a seamless go-live process.    Process Improvement & Compliance • Enhance testing processes by implementing best practices from leading consulting firms (e.g., Agile frameworks, DevOps integration, test                automation). • Ensure adherence to HIPAA, PHI, and PII regulations in all testing activities. • Optimize test strategies based on lessons learned from previous release • Maintain UAT documentation, including test scripts, defect logs, and status repor Minimum Requirements Education & Years of Experience • Bachelor’s degree and at least 6 years of relevant professional experience. • Master's degree in a relevant field may be substituted for 2 years of experience.     Experience, Knowledge, & Skills o 5+ years of experience in UAT, quality assurance, and software testing. o Experience managing programs involving multiple stakeholders and/or vendors. o Ability to thrive in complex and evolving environments. o Exceptional interpersonal, problem-solving, and analytical skills. o Strong project management experience, preferably in a consulting or government environment. o Experience working with multi-vendor environments and in managing outsourced testing teams Knowledge of Agile and Scrum for testing. Hands-on experience with test management tools (JIRA, ALM, etc.). o Expertise in cloud-based SaaS solutions and API testing. o Familiarity with data analytics, SQL, and business intelligence tools for validation. o Understanding of software development lifecycle (SDLC) and release management. Skills: o Strong problem-solving, analytical, and stakeholder management skills. o Experience with test management tools, defect tracking systems, and UAT governance. o Ability to work in a fast-paced, multi-vendor environment Preferred Qualifications • Certifications in PMP, ISTQB, or CSM is good to have • Experience with CMS integrations and requirements. • Experience with test automation tools (Selenium, Tosca, or Cypress). • Experience with state health insurance Exchanges, the federal Exchange, or EDE partners. • Understanding of the Affordable Care Act (ACA) and the individual market, including federal and state health insurance policies and programs. • Experience working with and/or processing 834 enrollment files. • Experience working in and/or with governmental agencies. Key Enhancements & Skillsets: Analytical Thinking & Problem-Solving – Emphasized risk assessment, impact analysis, and test optimization. Project Management & Agile – Integrated Agile, Scrum, and SAFe methodologies for better test execution. Technical Proficiency – Added cloud-based testing, automation tools, API validation, and SQL querying. Stakeholder Collaboration – Strengthened business-technology alignment and vendor coordination. Process Improvement – Incorporated test automation, DevOps integration, and best practices for continuous improvement. 
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.