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Ivd In Vitro Diagnostics Jobs in Delaware (NOW HIRING)

Bebee Healthcare

NUCLEAR MEDICINE TECHNOLOGIST

Lewes, DE · On-site

$36.57/hr

Performs in vivo and in vitro diagnostic Nuclear Medicine procedures according to established protocols. Maintains a daily activities log. Ensures appropriate storage and ordering of supplies for the ...

Beebe Healthcare

NUCLEAR MEDICINE TECHNOLOGIST

Lewes, DE · On-site

$56.68/hr

Performs in vivo and in vitro diagnostic Nuclear Medicine procedures according to established protocols. Maintains a daily activities log. Ensures appropriate storage and ordering of supplies for the ...

Beebe Healthcare

NUCLEAR MEDICINE TECHNOLOGIST

Lewes, DE · On-site

$56.68/hr

Performs in vivo and in vitro diagnostic Nuclear Medicine procedures according to established protocols. Maintains a daily activities log. Ensures appropriate storage and ordering of supplies for the ...

Bebee Healthcare

NUCLEAR MEDICINE TECHNOLOGIST

Lewes, DE · On-site

$36.57/hr

Performs in vivo and in vitro diagnostic Nuclear Medicine procedures according to established protocols. Maintains a daily activities log. Ensures appropriate storage and ordering of supplies for the ...

Beebe Healthcare

NUCLEAR MEDICINE TECHNOLOGIST

Lewes, DE · On-site

$36.57 - $56.68/hr

Performs in vivo and in vitro diagnostic Nuclear Medicine procedures according to established protocols. Maintains a daily activities log. Ensures appropriate storage and ordering of supplies for the ...

Bebee Healthcare

NUCLEAR MEDICINE TECHNOLOGIST

Lewes, DE · On-site

$36.57/hr

Performs in vivo and in vitro diagnostic Nuclear Medicine procedures according to established protocols. Maintains a daily activities log. Ensures appropriate storage and ordering of supplies for the ...

Beebe Healthcare

NUCLEAR MEDICINE TECHNOLOGIST

Lewes, DE · On-site

$36.57 - $56.68/hr

Performs in vivo and in vitro diagnostic Nuclear Medicine procedures according to established protocols. Maintains a daily activities log. Ensures appropriate storage and ordering of supplies for the ...

All JobsIvd In Vitro Diagnostics JobsIvd In Vitro Diagnostics Jobs in Delaware

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.

What are popular job titles related to Ivd In Vitro Diagnostics jobs in Delaware?

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

What job categories do people searching Ivd In Vitro Diagnostics jobs in Delaware look for?

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

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

Cities in Delaware 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 Delaware as of August 2026, with employment types broken down into 3% Internship, 1% As Needed, 83% Full Time, 10% Part Time, 2% Contract, and 1% Nights. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.

Corporate Quality and Clinical Auditor

Hologic

Newark, DE • On-site

Full-time

Re-posted 10 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

178th of 490 rated machine equipment manufacturers

Job description


As a Corporate Quality and Clinical Auditor, you will support company-wide clinical quality and compliance programs through execution of risk-based audits, audit system oversight, regulatory intelligence, and inspection readiness. This role evaluates clinical quality systems, supports global regulatory compliance and provides expert leadership across internal and external audit activities. This role develops and maintains audit electronic audit systems, analyzes data for reporting, and supports risk-based and special audits, including those related to new acquisitions and transfers.
The auditor evaluates and monitors corrective actions, supports FDA inspections and external audits, and facilitates inspection-readiness training.
Essential Duties and Responsibilities
  • Manage key components of the compliance audit program under the Community of Practice for Quality Audits to ensure process and product conformance per company and regulatory requirements.
  • Evaluate, maintain, and analyze compliance audit metrics to ensure internal and external audit results are properly tracked across Hologic locations.
  • Support the Director of Internal Audit in the annual Compliance Audit report for the Executive team.
  • Develop and manage special audit tasks and support the risk-based approach for clinical audits.
  • Evaluate and monitor corrective actions from clinical audits; coordinate joint audits, special compliance gap assessments, and FDA inspection readiness training.
  • Support FDA and external audit activities as assigned.
  • Identify compliance issues, evaluate risks associated with clinical activities, and drive internal manufacturing compliance improvements to reduce compliance risk.
  • Support clinical audit activities for recently acquired companies or products, maintain and update the electronic audit module, assess external regulatory trends, and provide strategic updates on clinical compliance performance.
Supervisory Responsibilities
  • ☒ None
Qualifications Education Basic Qualifications
  • B.S. in Engineering, Science, or related field. (Strongly recommended focus in Electrical or Electronic engineering, Chemist, Microbiology or Science)
  • Active Certification as IRCA, RABQSA, ASQ CMDA (preferred), ISO 13485 Lead Auditor, EU MDR or EU IVDR Lead Auditor Qualification by a recognized organization
  • Minimum of 8 years of experience in one or more of the following areas: Quality Engineering, R&D, Compliance, Quality Operations with focus in installation, servicing, refurbishing activities, chemical compliance, clinical studies, current Good Clinical Practices
  • Minimum of 5 years' experience as a Clinical or Lead Auditor in a regulated industry
Experience & Skills Regulatory and Technical Knowledge Required
Documented courses with assessments are preferred
  • ISO 14155:2020 - Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 20916:2019 - In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects
  • ISO 14971:2019 - Medical devices - Application of risk management to medical devices
  • ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO/IEC 27001 - Information security for clinical data systems
  • Regulation (EU) 2017/745 - Medical devices (MDR)
  • Regulation (EU) 2017/746 - In vitro diagnostic medical devices (IVDR)
  • UK Medical Devices Regulations 2002 (as amended)
  • US FDA 21 CFR Parts 11, 50, 54, 56, 812
  • US FDA 21 CFR Parts 800-898 - Medical Device Regulations (incl. 21 CFR 820 - QMSR)
  • US FDA Bioresearch Monitoring Program (BIMO)
  • Canada: SOR/98-282 - Medical Devices Regulations
  • Australia: Therapeutic Goods (Medical Devices) Regulations 2002
  • Japan: Pharmaceuticals and Medical Devices Act (PMD Act)
  • Brazil: Law No. 6.360/1976 and associated ANVISA medical device RDCs
  • European Union: Regulation (EU) 2017/745 - Medical Devices (MDR); Regulation (EU) 2017/746 - In Vitro Diagnostic Medical Devices (IVDR)Good Clinical Practices and Good Laboratory Practices
  • Statistical techniques and sampling plans
  • Process, equipment and design validation, test method validation
  • Software validation requirements (product and non-product)
  • Expert skills using SharePoint, Teams, PowerPoint and Excel
Highly desired
  • Additional working knowledge of European Standards and Regulations
  • Experience in other global regulatory requirements e.g. Korea, China, Swiss, UK etc.
  • Working knowledge of Artificial Intelligence regulations and standards
  • Strong project management and failure investigation/root cause analysis skills
  • Current ASQ certifications, e.g. CMDA, CQA and CQE
  • Excellent written and verbal communication skills
  • Strong interpersonal and cross-functional leadership skills
  • Multilingual e.g. English and Spanish, German, French, or Chinese

Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $138,000-$230,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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