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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 ...

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 ...

Qiagen

Senior Scientific Expert IVD

Germantown, MD

$82K - $137K/yr

The ideal candidate will have experience in developing in vitro diagnostic (IVD) products in a regulated environment. A strong background in immunology/molecular biology is critical. The Senior ...

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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 Jul 3, 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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What cities are hiring for Ivd In Vitro Diagnostics jobs? Cities with the most Ivd In Vitro Diagnostics job openings:
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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 June 2026, with employment types broken down into 9% Locum Tenens, 90% Full Time, and 1% Summer. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution, with an average salary of $107,970 per year, or $51.9 per hour.
Principal Device Quality Engineer - IVD devices SME (JP9691-S)

Principal Device Quality Engineer - IVD devices SME (JP9691-S)

3 Key Consulting

South San Francisco, CA • On-site

Other

Posted 4 days ago

Job description


Job Title: Principal Device Quality Engineer - IVD devices SME(JP9691-S)
Location: Thousand Oaks, California OR San Francisco, California OR Cambridge, Massachusetts
Employment Type: Contract
Business Unit: Digital Health & Diagnostics Quality
Duration: 12 months with likely extensions
Job posting date: 1/20/2022
Note: Remote until Covid restrictions are lifted.
3 Key Consulting is hiring a Principal Device Quality Engineer - IVD devices SME for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Manager is open to candidates working remotely until restrictions are lifted
  • Candidates must have 5+ years working with IVD devices. Must be IVD subject matter expert.
  • This key role in the Quality organization will assist with the co-development, commercialization, and lifecycle management for diagnostic and companion diagnostic devices (IVD's) to support the client therapeutics.
  • The role will be highly visible, interacting with cross-functional internal European and U.S. management and technical team members, and multiple IVD manufacturers, to prepare for and execute activities including manufacturer due diligence and evaluation, manufacturer auditing, design control, inspection readiness and lifecycle management.
  • The position will report to a member of the Device Quality department leadership team and provide thought leadership and current best practices surrounding considerations and continued development of internal processes related to control of IVDs. The staff member will report to the Corporate Quality function at the Thousand Oaks, California headquarters.
  • Train and educate key functional partners and management on regional and international IVD requirements, standards and regulations
  • Suggest and participate in improvements to the quality system, particularly related to IVDs
  • Provide Quality leadership for regulatory interactions for IVDs
  • Review and approve procedures and work Instructions
  • Specifically, this role will employ quality principles and company's procedures including but not limited to the areas of Purchasing Controls, Design Controls, Change Controls and NC/CAPA, Risk Management, Human Factor Engineering, Process Validation, and Manufacturing and Distribution, to ensure co-development and sustainment of IVD products complies with applicable regulations and standards. Such devices may include (but are not limited to):
    • IVDs intended to diagnose a condition client's therapeutics treat
    • IVDs intended for client drug titration
    • IVDs intended to monitor a condition client's therapeutics treat

Basic Qualifications
  • Doctorate degree and 2 years of directly related experience OR
  • Master's degree and 6 years of directly related experience OR
  • Bachelor's degree and 8 years of directly related experience OR
  • Associate's degree and 10 years of directly related experience OR
  • High school diploma / GED and 12 years of directly related experience

Preferred Qualifications
  • BS in Science/Engineering - preferably chemistry, biology, software, mechanical, or electrical engineering.
  • 5+ years of Quality, Engineering or Operations experience in the IVD medical device industry
  • Experience with quality systems including: 21 CFR 820, European Medical Device Directives (MDD) and Medical Device Regulations (MDR), IEC 62304, ISO 13485, ISO 14971, IEC 62366.
  • Knowledge of Medical Device Design Controls, particularly for in vitro devices. Experience working in in vitro device development, manufacturing or validation function is a plus.
  • Experience with designing and executing IVD clinical trials is a plus, particularly as part of a co-development agreement between a biopharmaceutical manufacturer and an IVD manufacturer
  • Experience in interacting with notified bodies and regulatory agencies in an inspection setting for In Vitro devices.
  • Strong project management skills including the ability to manage multiple workflows simultaneously and work within business processes as well as quality management systems
  • Ability to work in a cross-functional team environment and to influence personnel across functions and at all levels
  • High personal integrity with a positive attitude and a strong work ethic
  • Experience in driving improvement and implementing change
  • Demonstrated the ability to effectively work independently and with individuals located in remote locations
  • Inter-personal skills and demonstrated ability to teach lay staff quality principles

Top Must have Skill Sets:
  • Audits / inspections / quality agreements (purchasing controls)
  • Quality or Technical experience within a GMP regulated IVD manufacturer (IVDD, IVDR, FDA QSR)
  • Ability to teach high performing staff who have a device quality background, but not necessarily IVD experience

Employee Value Proposition:
Compelling, active and growing area of interest and innovation within precision medicine
Ability to gain experience from the "pharma" side of IVD and companion diagnostics
Broad exposure to many innovative IVD manufacturers
Red Flags:
  • No or minimal practical experience for IVD manufacturers
  • "Consultant" view, rather than "executor" view. We need people to do actual work, not give advice on policy and strategy
  • Poor communicator

Interview Process:
Initial phone screen followed by 3 or 4 behavioral interviews (combined, 1 day).
We invite qualified candidates to sendyour resume toresumes@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this position, please feel free to look at other positions on our websitewww.3keyconsulting.com. You are welcome to also sharethis posting withanyone you think might be interested in applying for this role.

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