ZipRecruiter

Log In

1

Iso Auditor Jobs in Delaware (NOW HIRING)

QPS, LLC

Auditor I - Lab

Newark, DE · On-site

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! Our compliance with applicable regulatory ...

Qnity

Quality Engineer

Newark, DE · On-site

$70K - $90K/yr

Lead ISO 9001, AS9100 Auditor certified. * Knowledge of quality and continuous improvement methodologies including Statistical Process Control (SPC),Lean Manufacturing and/ Six Sigma (Green Belt or ...

HireTalent

Inventory Control Clerk I

Newark, DE · On-site

$16.75 - $20/hr

Interact with internal and external auditors to explain documentation and processes. * Collaborate ... ISO standards, and Good Documentation Practices (GDP). Demonstrate a strong commitment to the ...

Arclin

$90 - $140/hr

Maintain and continually improve the site's ISO 14001 Environmental Management System. * Support ... external auditors. * Promote environmental awareness and compliance through employee training ...

next page

Showing results 1-20

All JobsIso Auditor JobsIso Auditor Jobs in Delaware

Iso Auditor information

See Delaware salary details

$10

$19

$46

How much do iso auditor jobs pay per hour?

As of Aug 30, 2026, the average hourly pay for iso auditor in Delaware is $19.22, according to ZipRecruiter salary data. Most workers in this role earn between $14.42 and $19.23 per hour, depending on experience, location, and employer.

What is an ISO auditor?

An ISO Auditor is responsible for evaluating an organization's processes, policies, and procedures to ensure compliance with ISO (International Organization for Standardization) standards. They conduct audits, identify areas for improvement, and provide recommendations to enhance efficiency, quality, and regulatory adherence. ISO Auditors may work independently or as part of a team, assessing documentation, interviewing employees, and ensuring that industry best practices are followed. Their goal is to help organizations maintain certifications and continually improve their management systems.

What are the key skills and qualifications needed to thrive as an ISO auditor?

To thrive as an ISO Auditor, you need a solid understanding of ISO standards (such as ISO 9001, ISO 14001), auditing methodologies, and a relevant educational background in quality management or a related field. Familiarity with audit management software, document control systems, and professional certifications like ISO Lead Auditor are highly valued. Strong analytical skills, attention to detail, and clear communication help auditors conduct thorough assessments and build rapport with stakeholders. These skills ensure audits are effective, accurate, and drive continual improvement within organizations.

What are some typical challenges faced by ISO auditors in their daily work?

ISO Auditors often encounter challenges such as navigating complex organizational structures, ensuring full compliance with evolving standards, and maintaining objectivity during assessments. They may need to adapt quickly to different industries or work environments and manage tight audit schedules. Strong organizational skills and a collaborative approach are essential for overcoming these hurdles and delivering valuable audit findings. Successfully handling these challenges helps auditors build trust and drive meaningful quality improvements for their clients or employers.

How do I become an ISO auditor?

To become an ISO auditor, you typically need relevant work experience in quality management systems, such as ISO 9001, and complete a recognized ISO auditor training course. Certification from an accredited body, like IRCA or ASQ, is often required to perform audits independently. Developing skills in auditing, documentation, and understanding ISO standards is essential for this role.

How much do ISO auditors get paid?

ISO auditors typically earn between $50,000 and $90,000 annually, depending on experience, industry, and location. Certified auditors with specialized knowledge and experience tend to earn higher salaries, and some may work as consultants or contractors with variable pay rates.

What qualifications do you need to be an ISO auditor?

To become an ISO auditor, candidates typically need a relevant educational background such as a degree in quality management, engineering, or a related field. Professional certifications like ISO 9001 Lead Auditor or ISO 27001 Lead Auditor are often required, along with experience in quality management systems and strong analytical skills.

What are popular job titles related to Iso Auditor jobs in Delaware?

For Iso Auditor jobs in Delaware, the most frequently searched job titles are:

What job categories do people searching Iso Auditor jobs in Delaware look for?

The top searched job categories for Iso Auditor jobs in Delaware are:

Iso Auditor jobs near you
Infographic showing various Iso Auditor job openings in Delaware as of August 2026, with employment types broken down into 88% Full Time, 6% Part Time, 4% Contract, and 2% Nights. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $39,981 per year, or $19.2 per hour.

Corporate Quality and Clinical Auditor

Hologic

Newark, DE • On-site

Full-time

Re-posted 23 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

181st of 495 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.
#LI-AV1

What Hologic employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply