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In Vitro Diagnostics Jobs in Indiana (NOW HIRING)

Ortho Clinical Diagnostics

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in ...

Micro Typing Systems

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in ...

Siemens Healthineers

Biochemist 1

Elkhart, IN · On-site

$69K - $95K/yr

This Biochemist 1 position is in a group that provides monoclonal antibodies, recombinant and native proteins to support reagent manufacturing for in-vitro diagnostics. The candidate will perform ...

Siemens Healthineers

Biochemist 1

Elkhart, IN · On-site

$69K - $95K/yr

... In Vitro Diagnostics (IVD) assays. Test methods include but are not limited to: gel electrophoresis, spectrophotometric assays, ELISA, protein size exclusion chromatography, water purity analysis.

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In Vitro Diagnostics information

What is the highest paying laboratory job?

In the field of in vitro diagnostics, senior roles such as Laboratory Directors or Clinical Laboratory Managers typically have the highest salaries, often exceeding $100,000 annually. These positions require advanced certifications, extensive experience, and oversight of laboratory operations and compliance.

What are some jobs in diagnostic services?

Jobs in diagnostic services include roles such as laboratory technologists, clinical laboratory scientists, and medical laboratory technicians. These professionals perform tests on patient samples using specialized equipment and often require relevant certifications or degrees. They work in laboratories, hospitals, or diagnostic companies to support disease detection and patient care.

What is the field of in vitro diagnostics?

In vitro diagnostics (IVD) is a field focused on developing and using tests performed on samples such as blood, urine, or tissue outside the body to detect diseases, conditions, or infections. Professionals in this field often work with laboratory equipment, adhere to regulatory standards, and require knowledge of biology and chemistry to ensure accurate test results.

What are In Vitro Diagnostics?

In Vitro Diagnostics (IVDs) are medical tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. These tests are done outside the body, usually in a laboratory setting, and are essential for diagnosing illnesses, guiding treatment decisions, and monitoring overall health. IVDs include a wide range of products like blood glucose monitors, pregnancy tests, and tests for infectious diseases. They play a crucial role in modern healthcare by providing timely and accurate information to both patients and healthcare providers.

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 biology, chemistry, or biomedical sciences, often supported by a relevant degree and laboratory experience. Familiarity with diagnostic instruments, quality control systems, and regulatory standards (such as ISO 13485 or FDA requirements) is typically required. Strong analytical thinking, attention to detail, and effective communication skills help professionals excel in troubleshooting and team collaboration. These abilities ensure accurate testing, compliance, and the reliable delivery of diagnostic information crucial for patient care.

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

AspectIn Vitro DiagnosticsMedical Laboratory Technician
Required CredentialsCertification in IVD technologies, relevant degreesAssociate degree in medical laboratory technology, certification
Work EnvironmentManufacturing labs, quality control, product developmentHospital, clinical, or diagnostic labs
Industry UsageManufacturers, biotech firms, diagnostic companiesHospitals, clinics, diagnostic laboratories

In Vitro Diagnostics professionals focus on developing, testing, and manufacturing diagnostic devices and kits, often working in labs or production settings. Medical Laboratory Technicians perform tests on patient samples in clinical labs. While both roles require laboratory skills and certifications, In Vitro Diagnostics specialists are more involved in product development and quality assurance, whereas Medical Laboratory Technicians focus on clinical testing and patient diagnostics.

What are some common challenges faced by professionals working in In Vitro Diagnostics (IVD) and how can they be addressed?

Professionals in In Vitro Diagnostics often face challenges such as keeping up with rapidly evolving technologies, ensuring strict regulatory compliance, and troubleshooting complex instrumentation. Staying updated through continuous education and active participation in industry forums can help manage technological changes. Collaborating closely with cross-functional teams—including R&D, regulatory affairs, and quality assurance—can ensure compliance and effective problem-solving, while regular hands-on training supports effective instrument maintenance and troubleshooting.

What are the career paths in molecular diagnosis?

In molecular diagnosis, career paths include roles such as molecular technologist, research scientist, clinical laboratory director, and quality assurance specialist. These positions often require knowledge of molecular biology techniques, laboratory skills, and relevant certifications, with opportunities to advance into management or specialized research roles.
What are popular job titles related to In Vitro Diagnostics jobs in Indiana? For In Vitro Diagnostics jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching In Vitro Diagnostics jobs in Indiana look for? The top searched job categories for In Vitro Diagnostics jobs in Indiana are:
What cities in Indiana are hiring for In Vitro Diagnostics jobs? Cities in Indiana with the most In Vitro Diagnostics job openings:
In Vitro Diagnostics jobs near you
Infographic showing various In Vitro Diagnostics job openings in Indiana as of July 2026, with employment types broken down into 1% As Needed, 86% Full Time, 9% Part Time, 3% Contract, and 1% Summer. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.

Quality Associate II - QMS

EKF Diagnostics Inc

South Bend, IN • On-site

Full-time

Re-posted 5 days ago

Job description

Job Type
Full-time
Description
SUMMARY OF POSITION:
The Quality Associate II - Quality Management System (QMS) supports the development, maintenance, and continuous improvement of the QMS in alignment with ISO 13485, ISO 9001, FDA QMSR, and, as applicable, pharmaceutical cGMP requirements (21 CFR Parts 210/211 and ICH Q7), among other applicable requirements. This role focuses on CAPA, Internal Audits, Supporting External Audits, Training, Batch Release, and Supplier Qualification and Quality Agreements, QMS-level risk management. The position ensures the QMS remains compliant, effective, and inspection-ready.
ESSENTIAL FUNCTIONS, included but not limited to:
QMS Quality Oversight
  • Administer and maintain QMS processes including CAPA, internal audits and training SOPs.
  • Lead or support CAPA investigations, ensuring strong root-cause analysis, effectiveness checks, and timely closure.
  • Support internal audit planning, execution, reporting, and follow-up activities.
  • Support QA Manager and QMS Documentation Lead with document control and change management activities, including SOPs, forms, labels, IFUs, and controlled templates.
  • Maintain and oversee the training management system.
  • Support QA review of the feedback and complaint handling activities, escalate to Regulatory as needed.
  • Perform quality review of supplier approval process, including risk assessments.
  • Review and approve batch records and final product documentation.
  • Support risk management activities (ISO 14971), as needed.
  • Perform trend analysis across QMS processes (CAPA, complaints, audits, training, etc.) and escalate trends. Prepare reports for quality review board, management review, etc.
  • Support the training program by managing the training matrix, ensuring training assignments are accurate, current, and aligned with role requirements; monitor completion status and maintain compliant training records.

Batch Release
  • Review and approve batch records and final product documentation.
  • Ensure completeness, accuracy, and compliance of DHRs, COAs, and supporting documentation.

Documentation & Compliance
  • Ensure quality related documentation complies with ISO 13485, ISO 9001 and FDA 21 CFR 820 (QMSR), and other applicable requirements.
  • Draft, revise, and maintain SOPs, work instructions, forms, and controlled documents as required.
  • Support and participate in internal and external audits.
  • Ensure that batch reviews are conducted by personnel independent from the manufacturing, production or testing activities to ensure objective assessment and prevent conflicts of interest.

Documentation & Compliance
  • Ensure quality related documentation complies with ISO 13485, ISO 9001 and FDA 21 CFR 820 (QMSR)
  • Support operations in ensuring their documentation complies with requirements as applicable, ISO 13485, ISO 9001 and FDA 21 CFR 820 (QMSR), etc.
  • Draft, revise, and maintain SOPs, work instructions, forms, and controlled documents related to operations quality.
  • Support internal and external audits by providing quality records and participating in audit activities.

Training & Cross-Functional Support
  • Provide training on QMS, Continuous Improvements GMP, GDP, and compliance requirements, as applicable.
  • Cross-train with the Quality team and provide support during peak workload periods.
  • Collaborate with Manufacturing, Procurement, Technical Support, Compliance (QC, RA) and other departments as applicable to ensure compliant operations.

OTHER FUNCTIONS:
  • Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area.
  • Assist as needed in other areas of the Company where training requirements have been completed.
  • Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:
  • Perform other duties as assigned.

TRAVEL:
  • 5% annually for supplier audits or cross-site activities.

Requirements
REQUIRED QUALIFICATIONS:
  • Bachelor's degree (B.A. /B.S.) from an accredited college or university in a science related field.
  • Legally authorized to work in the United States.
  • Three (3) years of quality experience in relation to medical devices or In vitro diagnostics devices.
  • Strong knowledge of various standards and regulations such as ISO 9001, ISO 13485, ISO 14971, Quality Management System Regulation (QMSR) (21 CFR Part 820).

PREFERRED QUALIFICATIONS:
  • Five (5) years proven quality experience in relation to In vitro diagnostics devices.
  • Knowledgeable supplier programs, CAPA, Internal Audits, Risk Management
  • Working knowledge of pharmaceutical cGMP requirements (21 CFR Parts 210/211 and ICH Q7); beneficial as the organization transitions from a CMO to a CDMO.

BASIC SKILLS AND ABILITIES:
  • Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
  • Good computer skills including Microsoft Word, Excel, Outlook.
  • Detail oriented with a high level of accuracy, efficiency, and accountability.
  • Excellent organizational skills to meet goals and set priorities.
  • Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Initiative to offer new innovative ideas and improve processes.
  • Ability to work independently and as a member of various teams and committees.

REASONING ABILITIES:
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Must have strong analytical and planning skills sufficient to determine resources and time required to complete projects

LANGUAGE SKILLS:
  • Good written and oral communication skills; with the ability to interface well with management, internal employees, FDA, notified bodies, and other international regulatory authorities.
  • Ability to read, analyze, and interpret general business periodicals, professional scientific and technical journals, technical procedures, financial reports, legal documents, and governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

MATHEMATICAL SKILLS:
  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

VISUAL ACUITY:
  • Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.

PHYSICAL DEMANDS:
  • Must be able to wear and work in personnel protective equipment (PPE) as required.
  • Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
  • Stationary position sitting for prolonged periods of time while utilizing standard office tools.
  • Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; dexterity and coordination necessary to handle files and single pieces of paper.
  • The ability to hear, understand, and distinguish speech.
  • Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations.
  • Frequently lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds, and rarely lift and/or move up to 50 pounds.
  • Often move about inside the facility to access office machinery, correspond with other departments, attend meetings/training, etc.
  • Occasionally reaching for items above and below desk level.
  • Occasionally required to climb or balance; squat, stoop, kneel, crouch, or crawl, and smell.

ENVIRONMENT CONDITIONS:
  • Well lit, heated/air-conditioned indoor office setting with adequate ventilation.
  • The noise level in the work environment is low.
  • Periodic exposure to low temperatures in controlled refrigerators and/or freezers.
  • Some exposure to hazards or physical risks which require following basic safety precaution

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