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From Home Fda Inspector Jobs in Delaware (NOW HIRING)

Hologic Inc.

Quality Inspector 2

Newark, DE

You'll play a key part in maintaining compliance with FDA compliance, supporting investigations ... hear from you! Knowledge: * Familiarity with Good Manufacturing Practices (GMP) and Good ...

Hologic

Quality Inspector 2

Newark, DE · On-site

You'll play a key part in maintaining compliance with FDA compliance, supporting investigations ... hear from you! Knowledge: * Familiarity with Good Manufacturing Practices (GMP) and Good ...

Home Genius Exteriors

$90K - $225K/yr

In just 7 years, we've grown from $3M to nearly $500M by delivering A Different Experience for ... Inspect homes and recommend roofing, siding, windows, gutters, and doors * Present financing ...

Hologic

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

... from the field. Works with cross functional team in implementation of improvements or corrections ... and FDA inspections * Supports monthly Quality Investigation Review boards, preparing and ...

Hologic Inc.

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

... from the field. Works with cross functional team in implementation of improvements or corrections ... and FDA inspections * Supports monthly Quality Investigation Review boards, preparing and ...

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All JobsFda Inspector JobsFrom Home Fda Inspector JobsFrom Home Fda Inspector Jobs in Delaware

From Home Fda Inspector information

How much does an FDA auditor get paid?

FDA auditors, who typically work for the Food and Drug Administration, earn a median annual salary of around $70,000 to $100,000, depending on experience, location, and level of responsibility. Salaries can increase with seniority, specialized certifications, and years of service, and auditors often work in regulatory, compliance, or quality assurance environments.

Is it hard to get hired by the FDA?

Getting hired as a home FDA inspector can be competitive, as the role requires relevant experience in food safety, inspections, or regulatory compliance, along with passing background checks and assessments. Candidates often need a combination of education, certifications, and knowledge of FDA regulations to improve their chances of employment.

How do I become an FDA inspector?

To become an FDA inspector, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or food science, along with experience in food safety, pharmaceuticals, or related areas. Applicants must pass a background check and may need to complete specialized training provided by the FDA. Certification or licensing is not required, but strong analytical skills and knowledge of regulatory standards are essential.

How much do FDA drug investigators make?

FDA drug investigators typically earn between $70,000 and $120,000 annually, depending on experience, location, and level of responsibility. They often hold a bachelor's degree in a relevant field and may require specialized training or certifications. Salaries can vary based on federal pay scales and whether the investigator is in a supervisory role.
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From Home Fda Inspector jobs near you
Infographic showing various From Home Fda Inspector job openings in Delaware as of July 2026, with employment types broken down into 10% Locum Tenens, 70% Full Time, 16% Part Time, 2% Contract, 1% Nights, and 1% Summer. 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 22 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

174th of 486 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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