Gainesville Quality Assurance & Control Job Listings

Quality Assurance Manager63846021235969120

Workable

Quality Assurance Manager

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: QA Manager Location: Alpharetta/Chamblee Position Type: 5 days Onsite Exempt Position Job Summary: We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have at least 7 years of experience in the IVD industry, with a strong background in quality management systems, regulatory compliance, and team leadership. Key Responsibilities: Quality Systems & Compliance Develop, implement, and maintain Quality Management Systems (QMS) in accordance with, US FDA, ISO 13485, and applicable regulations. Lead internal and external audits, regulatory inspections, and corrective action plans (CAPAs). Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity. Process & Product Quality Assurance Develop and enforce Standard Operating Procedures (SOPs) and best practices to ensure consistent quality across manufacturing operations. Collaborate with R&D, production, and regulatory affairs teams to ensure new products and processes meet quality standards. Monitor and analyze quality metrics (KPIs) to drive continuous improvement initiatives. Ensure adherence to Good Documentation Practices (GDP) and data integrity policies. Leadership & Team Development Lead, mentor, and develop the QA team, fostering a culture of quality, compliance, and continuous improvement. Train manufacturing and quality teams on quality systems, and root cause analysis (RCA) methodologies. Serve as the primary point of contact for quality-related issues and escalations. Risk Management & Continuous Improvement Identify quality risks and implement proactive mitigation strategies. Lead investigations and root cause analyses for product defects, deviations, and non-conformances. Drive LEAN, Six Sigma, or other process improvement initiatives to enhance efficiency and reduce waste. Stay updated on industry trends, new regulations, and technological advancements in medical device IVD quality assurance. Requirements Bachelor’s or Master’s degree in Biotechnology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. 7+ years of experience in quality assurance within biotech, pharmaceutical, or medical device manufacturing. 3+ years in a managerial or leadership role overseeing QA teams. Skills & Competencies Strong knowledge of US FDA, ISO 13485, and other regulatory standards. Experience with QA audits, inspections, CAPA investigations, and risk management. Proficiency in QMS software and documentation control systems. Strong analytical and problem-solving skills, with a data-driven approach to decision-making. Excellent leadership, communication, and cross-functional collaboration skills. Benefits Medical Insurance Plan Retirement Plan Paid Time Off Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

Alpharetta, GA, USA

Negotiable Salary

Quality Inspector - 1st Shift (Same Day Pay) $14-16hr Gainesville63392065610497121

Workable

Quality Inspector - 1st Shift (Same Day Pay) $14-16hr Gainesville

***********PLEASE READ BELOW***************** The Immediate Pay, Quality Inspector position offers individuals the opportunity to receive payment for their work on the same day they perform their duties. This position is designed to provide a quick and fair compensation system for workers who are seeking immediate income. Upon starting the job, workers will be paid for their first day of work (ONLY) at the end of that day. However, it is important to note that if a worker does not show up for their second day of work without prior notice or valid reason, they will be terminated from the position. This is a W2 position. You will not be considered if you do not perform video screen. Overall Purpose of the Quality Inspector Provide Quality services and support for all missions assigned to a manufacturing or warehouse site while ensuring a healthy and safe work environment. Reports to Site Supervisor/Site Leaders Responsibilities (To include but not limited to the following) Client Relationship & Business Development Act as an impartial third party between the production source and the customer facility to ensure the product meets set criteria Operations Check/inspect manufactured parts or products for defects Read and follow work instructions and general processes Use measuring or testing equipment as needed Ensure products meet quality standards Display excellent customer service Must comply with local and company Health & Safety legislation, laws, and policies Organization & Management Collect and record data Technical Utilize company portal for time recording and policy acknowledgements Other Any other duties as assigned Knowledge, skills, abilities Hard skills Requirements Must be able to speak and read in the English language Good communications skills Must be able to multi-task Ability to work in a fast-paced environment Ability to handle sensitive and confidential material Ability lift /move 50 pounds Must have reliable transportation

Gainesville, GA, USA

Negotiable Salary

Quality Inspector 2nd Shift (Same Day Pay) $15-17hr Gainesville63500029645443122

Workable

Quality Inspector 2nd Shift (Same Day Pay) $15-17hr Gainesville

***********PLEASE READ BELOW***************** The Immediate Pay, Quality Inspector position offers individuals the opportunity to receive payment for their work on the same day they perform their duties. This position is designed to provide a quick and fair compensation system for workers who are seeking immediate income. Upon starting the job, workers will be paid for their first day of work (ONLY) at the end of that day. However, it is important to note that if a worker does not show up for their second day of work without prior notice or valid reason, they will be terminated from the position. This is a W2 position. You will not be considered if you do not perform video screen. Overall Purpose of the Quality Inspector Provide Quality services and support for all missions assigned to a manufacturing or warehouse site while ensuring a healthy and safe work environment. Reports to Site Supervisor/Site Leaders Responsibilities (To include but not limited to the following) Client Relationship & Business Development Act as an impartial third party between the production source and the customer facility to ensure the product meets set criteria Operations Check/inspect manufactured parts or products for defects Read and follow work instructions and general processes Use measuring or testing equipment as needed Ensure products meet quality standards Display excellent customer service Must comply with local and company Health & Safety legislation, laws, and policies Organization & Management Collect and record data Technical Utilize company portal for time recording and policy acknowledgements Other Any other duties as assigned Knowledge, skills, abilities Hard skills Requirements Must be able to speak and read in the English language Good communications skills Must be able to multi-task Ability to work in a fast-paced environment Ability to handle sensitive and confidential material Ability lift /move 50 pounds Must have reliable transportation

Gainesville, GA, USA

Negotiable Salary

Quality Inspector - 1st Shift (Same Day Pay) $16-18hr (Flowery Branch)63499970449153123

Workable

Quality Inspector - 1st Shift (Same Day Pay) $16-18hr (Flowery Branch)

***********PLEASE READ BELOW***************** The Immediate Pay, Quality Inspector position offers individuals the opportunity to receive payment for their work on the same day they perform their duties. This position is designed to provide a quick and fair compensation system for workers who are seeking immediate income. Upon starting the job, workers will be paid for their first day of work (ONLY) at the end of that day. However, it is important to note that if a worker does not show up for their second day of work without prior notice or valid reason, they will be terminated from the position. This is a W2 position. You will not be considered if you do not perform video screen. Overall Purpose of the Quality Inspector Provide Quality services and support for all missions assigned to a manufacturing or warehouse site while ensuring a healthy and safe work environment. Reports to Site Supervisor/Site Leaders Responsibilities (To include but not limited to the following) Client Relationship & Business Development Act as an impartial third party between the production source and the customer facility to ensure the product meets set criteria Operations Check/inspect manufactured parts or products for defects Read and follow work instructions and general processes Use measuring or testing equipment as needed Ensure products meet quality standards Display excellent customer service Must comply with local and company Health & Safety legislation, laws, and policies Organization & Management Collect and record data Technical Utilize company portal for time recording and policy acknowledgements Other Any other duties as assigned Knowledge, skills, abilities Hard skills Requirements Must be able to speak and read in the English language Good communications skills Must be able to multi-task Ability to work in a fast-paced environment Ability to handle sensitive and confidential material Ability lift /move 50 pounds Must have reliable transportation

Flowery Branch, GA, USA

Negotiable Salary