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Ivd In Vitro Diagnostics Jobs in Tennessee (NOW HIRING)

Integrated Resources INC

Quality Manager

Memphis, TN · On-site

... growing diagnostics company that is looking to expand their Quality team in Memphis TN. They are ... in laboratory or IVD/medical device environment with supervisory experience * Good working ...

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Ivd In Vitro Diagnostics information

What is 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.

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 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.

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For Ivd In Vitro Diagnostics jobs in Tennessee, the most frequently searched job titles are:

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The top searched job categories for Ivd In Vitro Diagnostics jobs in Tennessee are:

What cities in Tennessee are hiring for Ivd In Vitro Diagnostics jobs?

Cities in Tennessee with the most Ivd In Vitro Diagnostics job openings:

Ivd In Vitro Diagnostics jobs near you
Infographic showing various Ivd In Vitro Diagnostics job openings in Tennessee as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 9% Part Time, 2% Contract, and 1% Nights. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.

Laboratory Operations & Manufacturing Manager

Insight Molecular Diagnostics Inc

Nashville, TN • On-site

$105K - $110K/yr

Full-time

Posted 6 days ago

Job description

Who we are:

Insight Molecular Diagnostics is a precision diagnostics company with a mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey.

Mission of the role:

We are seeking a highly motivated and experienced Manager of Lab Operations & Manufacturing Manager to join our team in a permanent, full-time capacity. This individual will oversee both the technical laboratory ecosystem and the formulation and quality control testing of In Vitro Diagnostic (IVD) medical device products.

This role serves as a critical bridge between Product Development, Manufacturing, and Quality Assurance. The ideal candidate will ensure efficient day-to-day operations, lead process validation and design transfer, and enforce compliant execution of laboratory and manufacturing processes. All activities must strictly align with ISO 13485, FDA QSR (21 CFR 820), GMP principles, and CLIA/CAP design control frameworks.

Your day-to-day: 

Laboratory & Production Operations

  • Coordinate daily laboratory scheduling and workload prioritization.
  • Schedule and conduct manufacturing and formulation activities, including reagent preparation, assembly, sampling, labeling, and in-process quality checks following approved batch records and SOPs.
  • Manage operational readiness for active studies, ensuring continuity across projects, personnel, reagent/consumable inventory, equipment status, and workspace coordination.
  • Coordinate with Leadership and Project Management to monitor execution of active studies to ensure continuity across projects and personnel.
  • Establish, maintain, and scale laboratory organization, cleanliness, and operational standards to support evolving assay development needs.
  • Improve communication, handoff processes, and operational training across laboratory and production personnel.
  • Oversee laboratory personnel adherence to laboratory best-practices and ensure that documentation, protocols and reports are written comprehensively and consistent with IVD industry standards.

Equipment & Facility Oversight

  • Maintain comprehensive oversight of laboratory and manufacturing equipment, including preventive maintenance, calibrations, assets records, and qualification protocols and records (IQ/OQ/PQ).
  • Coordinate equipment troubleshooting, vendor service, and operational uptime.
  • Track facility-related operational issues including HVAC, humidity, power stability, and environmental controls.

Quality Systems, Documentation & Compliance

  • Apply working knowledge of GMP principles, ISO 13485, and 21 CFR 820 requirements to ensure process consistency and compliance
  • Maintain laboratory notebooks, batch records, maintenance logs, and validation protocols in a complete, traceable manner following quality assurance requirements.
  • Identify and access process risks, implement mitigations, and escalate gaps between documented procedures and operational practices.
  • Coordinate laboratory operational readiness for audits, inspections, and product development activities.

Team Coordination

  • Manage and coordinate staff scheduling, task ownership, and study progression.
  • Work collaboratively with scientists and managers to support assay development and validation efforts.
  • Facilitate operational meetings and daily maintenance activities.
  • Assist with onboarding and operational training of laboratory personnel.

Resource & Inventory Management

  • Coordinate vendor relationships.
  • Establish, maintain, and forecast reagent, consumable, and raw material management processes.
  • Coordinate laboratory inventory and consumable management to prevent workflow disruptions due to material shortages or equipment downtime.
  • Implement and manage the laboratory inventory, supply management program, and forecasting of operational needs.

Continuous Improvement

  • Identify operational inefficiencies and implement sustainable laboratory systems.
  • Develop scalable operational workflows that support evolving assay development needs.
  • Partner with leadership to improve execution consistency and reduce operational risk.
  • Monitor laboratory key performance indicators.


What it takes to do this job:
 

  • Education and Experience:
    • Bachelor’s degree in biology, molecular biology, biochemistry, clinical laboratory science, or related field
    • 5+ years of laboratory experience in molecular diagnostics, biotechnology, clinical laboratory, medical device manufacturing, or regulated life sciences environment
    • 3+ years of direct experience in the IVD medical device or molecular diagnostic industry, with a demonstrated history of executing batch records, validation protocols, and QC testing.
  • Skills and Competencies:
    • Proven ability to manage competing priorities across multiple projects in a fast-paced, dynamic environment.
    • Familiarity with regulated quality systems (CLIA, CAP, ISO 13485, Design Control, GMP, and 21 CFR 820). Experience supporting FDA or Notified Body audits is preferred.
    • Exceptional written and verbal communication skills; ability to collaborate cross-functionally with senior leadership and scientific staff.

Physical Demands:

  • Standing, sitting, walking, bending, reaching, manual manipulation, and lifting 25 pounds.
  • Ability to have full-body movement
  • All candidates must take a color vision test. 
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for at least 50% of a typical working day.
  • Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.

 

Who you are:
 

  • You have a “do what it takes – no job is too small” team player and a positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed.
  • A team player who is curious, adaptable, and willing to learn new techniques or concepts.
  • Your organizational skills, attention to detail, and ability to multi-task are excellent.
  • A proactive problem-solver who takes ownership of assigned tasks.
  • You like building effective internal and partner relationships including with team members, clients, vendors, suppliers, and team members.

You will have the opportunity to: 

  • Improve patient outcomes.
  • Meaningfully impact the company’s short-term and long-term success.
  • Work collaboratively across all levels within the organization.
  • Grow your role as you see fit.
  • Learn everything there is to know about cancer diagnostic laboratories.
  • Create an inspiring workplace.