Quality Assurance Manager

1 week ago


Atlanta, Georgia, United States CorDx Full time
Job Title: Quality Manager

CorDx is a leading biotech organization dedicated to pushing the boundaries of innovation and supply in global health. With a global presence and a team of over 2,100 employees, we deliver rapid testing and point-of-care medical device solutions for infectious diseases, pregnancy, drugs of abuse, biomarkers, and more.

Job Summary:

We are seeking an experienced Quality Manager to join our team in the IVD industry. The ideal candidate will have a minimum of 10 years of relevant experience in medical device manufacturing, with a strong background in quality management systems, regulatory compliance, and ISO standards.

Key Responsibilities:

  1. Implement, manage, and improve our company's quality management system, with a focus on IVD products and equipment.
  2. Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA).
  3. Lead and participate in internal audits and management reviews of our quality system as a key member of the quality department.
  4. Manage the documentation of our quality management system, ensuring compliance with relevant standards and regulations.
  5. Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards.
  6. Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed.
  7. Update company documents in accordance with new or revised quality standards, laws, and regulations.
  8. Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements.

Requirements:

  1. Minimum Bachelor's degree in Science or related field.
  2. ISO 13485:2016 lead auditor certification preferred.
  3. Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards.
  4. Strong understanding of quality management principles and practices in the medical device industry.
  5. Excellent communication and interpersonal skills.
  6. Ability to work collaboratively in a team environment.
  7. Demonstrated problem-solving and analytical skills.
  8. Attention to detail and strong organizational skills.
  9. Minimum 10 years of experience in Medical devices, Quality Management, Regulatory compliance, and ISO standards.

Benefits:

  • Health Care Plan (Medical)
  • 401K
  • 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.



  • Atlanta, Georgia, United States Gable Search Group Full time

    Gable Search Group is seeking a Quality Assurance Manager to lead our team in ensuring the highest quality standards in our plant. The ideal candidate will have a strong background in quality control and assurance, with experience in supervising a team of quality technicians. The Quality Assurance Manager will be responsible for guiding our SQF certification...


  • Atlanta, Georgia, United States Gable Search Group Full time

    Gable Search Group is seeking a Quality Assurance Manager to lead our team in ensuring the highest standards of quality in our operations. The ideal candidate will have a strong background in quality control and assurance, with experience in supervising a team of quality technicians. The Quality Assurance Manager will be responsible for guiding our SQF...


  • Atlanta, Georgia, United States Affinity Executive Search Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Affinity Executive Search. The successful candidate will be responsible for developing and implementing quality control programs, ensuring compliance with regulatory requirements, and maintaining a safe and healthy work environment.Key ResponsibilitiesDevelop and...


  • Atlanta, Georgia, United States The Recruiting Pros Full time

    Quality Control Manager Job DescriptionWe are seeking a highly skilled Quality Control Manager to join our team at The Recruiting Pros. As a Quality Control Manager, you will be responsible for developing and implementing a comprehensive quality assurance management system to ensure product specifications are met across all US production facilities and...


  • Atlanta, Georgia, United States Affinity Executive Search Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Affinity Executive Search. The successful candidate will be responsible for developing and coaching a staff of QA Technicians and handling the Plant's Quality Control (QC) and Quality Assurance programs.Key ResponsibilitiesMaintain and grow our Safety Culture, ensuring...


  • Atlanta, Georgia, United States The Recruiting Pros Full time

    Quality Control Manager Job DescriptionWe are seeking a highly skilled Quality Control Manager to join our team at The Recruiting Pros. As a Quality Control Manager, you will be responsible for developing and implementing quality control systems to ensure that our products meet the highest standards of quality.Key Responsibilities:Develop and implement...


  • Atlanta, Georgia, United States Affinity Executive Search Full time

    Quality Assurance ManagerAt Affinity Executive Search, we are seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for developing and implementing quality control programs to ensure compliance with company and government procedures.Key Responsibilities:Maintain and grow our Safety...


  • Atlanta, Georgia, United States Gable Search Group Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Gable Search Group. As a Quality Assurance Manager, you will be responsible for managing a staff of Senior and Bench Technicians, as well as for the plant's Quality Control (QC) and Quality Assurance program to ensure compliance with company, customer, and government...


  • Atlanta, Georgia, United States Gable Search Group Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Gable Search Group. As a key member of our organization, you will be responsible for ensuring the highest quality standards in our production process.Key ResponsibilitiesDevelop and implement quality policies and procedures to ensure compliance with company and...


  • Atlanta, Georgia, United States Affinity Executive Search Full time

    Job Summary:Ambitious and results-driven Quality Assurance Manager sought to lead our team in developing and implementing effective quality control programs. If you have a passion for ensuring the highest standards of quality and safety, we encourage you to apply for this exciting opportunity.Key Responsibilities:Maintain and enhance our company's safety...


  • Atlanta, Georgia, United States Turner Construction Full time

    Job Title: Quality Assurance ManagerTurner Construction is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for planning, coordinating, and developing project-specific Quality Assurance/Quality Control (QA/QC) plans that incorporate policies and procedures necessary to deliver...


  • Atlanta, Georgia, United States Affinity Executive Search Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for developing and coaching a staff of QA and Sanitation Technicians, ensuring compliance with company and government procedures, and maintaining a safe work environment.Key ResponsibilitiesMaintain and grow our...


  • Atlanta, Georgia, United States Flik Hospitality Group Full time

    Quality Assurance ManagerFlik Hospitality Group is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and safety of our supplied goods, meeting USDA, FDA, and customer requirements.Key Responsibilities:Develop and execute product food safety and...


  • Atlanta, Georgia, United States Affinity Executive Search Full time

    Job Summary:Affinity Executive Search is seeking a highly skilled Quality Assurance Manager to oversee the plant's Quality Control (QC) and Quality Assurance program. The ideal candidate will have a strong background in quality management, excellent leadership skills, and the ability to ensure compliance with company, customer, and government procedures.Key...


  • Atlanta, Georgia, United States Flik Hospitality Group Full time

    Quality Assurance ManagerFlik Hospitality Group is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality assurance team, you will be responsible for developing and maintaining all QA programs, ensuring compliance with USDA, FDA, and customer requirements, and guaranteeing the quality and safety of supplied...


  • Atlanta, Georgia, United States Amadeus Full time

    Job TitleManager, Software Quality AssuranceAmadeus Travel Business Intelligence (BI) is seeking a seasoned professional to lead our Software Quality Assurance team. Our Travel BI products provide critical insights to our customers, enabling them to increase revenue and profitability. As a Manager, Software Quality Assurance, you will be responsible for...


  • Atlanta, Georgia, United States Flik Hospitality Group Full time

    About Flik Hospitality GroupFlik Hospitality Group is a leading provider of food and hospitality services, dedicated to delivering exceptional quality and safety to our clients. We are committed to hiring talented individuals who share our passion for food and hospitality.Job SummaryThe Quality Assurance Manager is responsible for developing and maintaining...


  • Atlanta, Georgia, United States Walmart Full time

    Job SummaryWe are seeking a highly skilled and experienced Quality Assurance/Systems Manager to join our team at Walmart. As a key member of our operations team, you will be responsible for ensuring the smooth operation of our logistics and distribution systems, while also driving quality and efficiency across our supply chain.Key ResponsibilitiesDevelop and...


  • Atlanta, Georgia, United States Tetra Tech Full time

    Job Title: Deputy Quality Assurance ManagerThis is a remote/hybrid position that supports the Environmental Government Services (EGS) Operating Unit (OU) Quality Assurance Manager in all aspects of corporate and programmatic quality assurance/quality control (QA/QC) functions.Key Responsibilities:Conducting audits and surveillances to ensure compliance with...


  • Atlanta, Georgia, United States Walmart Full time

    Job SummaryWe are seeking a highly skilled and experienced Quality Assurance/Systems Manager to join our team at Walmart. As a key member of our operations team, you will be responsible for ensuring the highest level of quality and efficiency in our systems and processes.Key ResponsibilitiesDevelop and implement quality assurance programs to ensure...