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Ivd In Vitro Diagnostics Jobs (NOW HIRING)

CorDx

Quality Manager

Atlanta, GA · On-site

Onsite - Atlanta Office We are seeking an experienced Quality Manager to join our team in the IVD (In Vitro Diagnostic) industry. The ideal candidate will have a minimum of 10 years of relevant ...

CorDx

Quality Manager

Atlanta, GA · On-site

Onsite - Atlanta Office We are seeking an experienced Quality Manager to join our team in the IVD (In Vitro Diagnostic) industry. The ideal candidate will have a minimum of 10 years of relevant ...

Fujirebio

Finishing Technician

Malvern, PA · On-site

$24.05/hr

Our in vitro diagnostics (IVD) technology powers critical tests across the globe's leading diagnostic platforms. We are a biomarker and diagnostic content provider that strengthens diagnostics for ...

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Ivd In Vitro Diagnostics information

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How much do ivd in vitro diagnostics jobs pay per year?

As of Jun 9, 2026, the average yearly pay for ivd in vitro diagnostics in the United States is $107,970.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,500.00 and $150,500.00 per year, depending on experience, location, and employer.

What is the difference between Ivd In Vitro Diagnostics vs Medical Laboratory Technician?

AspectIvd In Vitro DiagnosticsMedical Laboratory Technician
CredentialsTypically requires certification in IVD or related fields, such as CLIA certificationRequires an associate degree in medical laboratory technology and certification
Work EnvironmentManufacturing settings, quality control labs, or clinical laboratoriesHospital, diagnostic labs, or clinics
Industry UsageDesign, manufacturing, and quality assurance of diagnostic devicesPerforming tests, analyzing samples, and reporting results

Both roles are essential in the healthcare industry but focus on different aspects. Ivd In Vitro Diagnostics professionals mainly work in manufacturing and quality assurance of diagnostic tools, while Medical Laboratory Technicians perform testing and analysis in clinical settings. Understanding these differences helps clarify career paths and job expectations in the diagnostics industry.

What are the key skills and qualifications needed to thrive as an In Vitro Diagnostics (IVD) Specialist, and why are they important?

To thrive as an In Vitro Diagnostics (IVD) Specialist, you need a solid background in life sciences, laboratory techniques, and often a degree in biology, chemistry, biomedical engineering, or a related field. Familiarity with diagnostic instruments, laboratory information management systems (LIMS), and relevant regulatory certifications such as ISO 13485 or CLIA compliance is typically required. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for interpreting results and collaborating with healthcare professionals. These competencies ensure the accuracy and reliability of diagnostic testing, which is essential for patient care and regulatory compliance.

What are In Vitro Diagnostics (IVD)?

In Vitro Diagnostics (IVD) are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. These tests help detect diseases, conditions, or infections and are used in medical laboratories, hospitals, and even at home. IVD devices include things like blood glucose monitors, pregnancy tests, and COVID-19 test kits. They play a critical role in disease prevention, diagnosis, and monitoring treatment effectiveness.

What are some typical challenges faced by professionals working in In Vitro Diagnostics (IVD) roles?

Professionals in IVD often face challenges related to ensuring regulatory compliance, as the industry is highly regulated and standards can change frequently. Additionally, staying updated with rapid technological advancements and integrating new testing methodologies into existing workflows can be demanding. Collaboration across multidisciplinary teams—scientists, quality assurance, regulatory, and manufacturing—is essential, and effective communication is key to navigating complex projects. Balancing the need for innovation with strict quality and safety requirements is also a common challenge in this field.
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Ivd In Vitro Diagnostics jobs near you
Infographic showing various Ivd In Vitro Diagnostics job openings in the United States as of May 2026, with employment types broken down into 95% Full Time, and 5% Contract. Highlights an 90% In-person, 5% Hybrid, and 5% Remote job distribution, with an average salary of $107,970 per year, or $51.9 per hour.
Quality Manager

Quality Manager

CorDx

Atlanta, GA • On-site

Full-time

Medical, Retirement, PTO

Posted 7 days ago

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.  

Job Type: Full time  

Job Title: Quality Manager

Location: Onsite - Atlanta Office

We are seeking an experienced Quality Manager to join our team in the IVD (In Vitro Diagnostic) industry. The ideal candidate will have a minimum of 10 years of relevant experience in the medical device manufacturing sector, with a strong background in quality management systems, regulatory compliance, and ISO standards. The Quality Manager will play a critical role in implementing, managing, and improving our company's quality management system, with a focus on IVD products and equipment.

Key Responsibilities:

  1. Implement, manage, and improve the company's quality management system, with a primary 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 the company's quality system as a key member of the quality department.
  4. Manage the documentation of the company's 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 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.  

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