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Fda Auditor Jobs in Michigan (NOW HIRING)

Internal auditor with IATF/ISO certification Auditing Experience IATF 16949/ ISO 9001 VDA 6.3 ... Provide FDA with NCM review, as needed. * Work with EHS Management Systems (Responsible Care ...

Internal auditor with IATF/ISO certification Auditing Experience IATF 16949/ ISO 9001 VDA 6.3 ... Provide FDA with NCM review, as needed. * Work with EHS Management Systems (Responsible Care ...

$165K - $207K/yr

Strong knowledge of ICH-GCP guidelines and applicable FDA, EU, and international GCP regulations * Experience auditing CROs, investigator sites, vendors, and other GCP service providers * Experience ...

New

EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...

... with FDA's QMSR, ISO 13485, and Aspen's internal quality system. * Support onboarding of new ... Supplier Auditing & Compliance * Plan and execute a risk-based supplier audit program, conducting ...

... with FDA's QMSR, ISO 13485, and Aspen's internal quality system. * Support onboarding of new ... Supplier Auditing & Compliance * Plan and execute a risk-based supplier audit program, conducting ...

Internal Auditor Certified (GFSI Scope) * PCQI Certified * HACCP Certified * Knowledge of BRCGS ... Deep understanding of food safety regulations (FDA, HACCP, MDARD etc.). * Quality Assurance ...

New

Reviews all fresh product quality issues observed by DF auditors and aids in the decision either to ... Audits the fresh DF in accordance with FDA cGMP guidelines, the DF Food Safety Plan as it pertains ...

Quality Assurance-Fresh

Newport, MI · On-site

$52 - $76/hr

... FDA cGMP guidelines, the DF Food Safety Plan as it pertains to the Preventive Control Rule, and the DF Seafood HACCP plan, with oversight of the QA Supervisor.Identifies and communicates to auditors ...

... auditors (SQF, BRCGS), and internal support teams (Finance, HR, IT, OPEX) * The Site Manager will ... USDA/FDA regulations, GFSI Standards (SQF/BRCGS) * Working knowledge of Lockout/Tagout (LOTO ...

Sanitation Site Manager

Canton, MI · On-site

$85 - $125/hr

... party auditors (SQF, BRCGS), and internal support teams (Finance, HR, IT, OPEX). * Serve as the ... SSOPs, GMPs, Allergen Controls, USDA/FDA regulations, GFSI Standards (SQF/BRCGS). * Working ...

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Fda Auditor information

See Michigan salary details

$28.8K

$66.5K

$105.9K

How much do fda auditor jobs pay per year?

As of Sep 4, 2026, the average yearly pay for fda auditor in Michigan is $66,464.00, according to ZipRecruiter salary data. Most workers in this role earn between $46,600.00 and $85,900.00 per year, depending on experience, location, and employer.

What is an FDA auditor?

An FDA Auditor is responsible for inspecting facilities, processes, and documentation to ensure compliance with U.S. Food and Drug Administration (FDA) regulations. They review manufacturing practices, quality control systems, and regulatory filings for industries such as pharmaceuticals, medical devices, and food production. FDA Auditors may work for the FDA or for companies preparing for FDA inspections. Their role helps ensure public safety by verifying that products meet legal and quality standards.

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

To thrive as an FDA Auditor, you need a strong background in life sciences, regulatory compliance, and audit methodologies, usually supported by a relevant degree and professional certifications such as RAC or CQA. Familiarity with FDA regulations (such as 21 CFR), electronic quality management systems (eQMS), and audit management tools is essential. Attention to detail, critical thinking, and strong communication skills help auditors navigate complex regulatory settings and interact effectively with stakeholders. These competencies are crucial for ensuring companies meet rigorous FDA standards and maintain regulatory compliance.

What are the primary challenges FDA auditors face during compliance inspections?

FDA Auditors often encounter challenges such as interpreting complex and evolving regulatory guidelines, managing on-site audits in diverse environments, and reviewing extensive documentation under tight timeframes. They must adapt quickly to various industry settings, handle potentially uncooperative stakeholders, and maintain objectivity throughout their evaluations. Successfully overcoming these challenges requires resilience, up-to-date regulatory knowledge, and excellent people skills. These hurdles are a vital part of ensuring public health and safety by holding organizations to the highest standards of compliance.

How to become an FDA auditor?

To become an FDA auditor, candidates typically need a bachelor's degree in a relevant field such as life sciences, chemistry, or pharmacy, along with experience in quality assurance or regulatory compliance. Professional certifications like Certified Quality Auditor (CQA) or training in Good Manufacturing Practices (GMP) are often required or preferred. Strong attention to detail, knowledge of FDA regulations, and auditing skills are essential for success in this role.

What do FDA auditors make?

FDA auditors typically earn a salary that ranges from $60,000 to $100,000 annually, depending on experience, location, and employer. They may also receive benefits such as health insurance, paid time off, and sometimes overtime pay, especially when conducting inspections or audits outside regular hours.

What are the most commonly searched types of Fda Auditor jobs in Michigan?

The most popular types of Fda Auditor jobs in Michigan are:

Infographic showing various Fda Auditor job openings in Michigan as of August 2026, with employment types broken down into 80% Full Time, 14% Part Time, 4% Contract, and 2% Nights. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $66,464 per year, or $32 per hour.

Quality Specialist

AA2IT

Wyandotte, MI • On-site

$26/hr

Full-time

This job post has expired today. Applications are no longer accepted.


Job description

Title: Quality Assurance / Quality Auditor

Location: 1609 Biddle Avenue, Wyandotte MI

Pay Rate: $26/HR

Quality Auditor and Internal Quality control responsibilities working with team to help solve quality issues.

Internal auditor with IATF/ISO certification

Auditing Experience IATF 16949/ ISO 9001 VDA 6.3 preferred

Root Cause Problem solving 8D, 5why, Ishikawa PPAP, APQP knowledge Customer Specific Requirements Document Control

Bachelor's degree preferred

Responsibilities:

The position of the Quality Management Specialist for Nutrition and Health is designed to provide support to various plants, laboratories, warehouses, and tolling operations that manufacture, test, or handle Client products regulated by FDA and USDA.

Ensures compliance within the areas of federal, state, and local regulations for various sites. Works closely with Sales, Marketing, and Technical organizations to facilitate implementation of agreed upon customer requirements into internal operations.

Qualifications - Bachelors of Science Degree in Engineering, Science or related other technical field

Minimum 2 years • experience in a quality and/or product regulations with the ability to understand and interpret FDA, USDA and other quality and regulatory requirements. Strong written and oral communication, analytical, problem solving and organizational skills.

Ability to work independently and assist internal, as well as external customers Receptive to change and innovation with the ability to identify areas for improvement Able to multi-task and maintain a professional approach in a fast-paced business environment Skilled at working within a multi-functional organization - Multiple touch points

Quality Specific Skills-

  • Ability to develop and manage effective relationships in a highly matrix organization to drive alignment and decisions on Quality topics
  • Ability to utilize a deep understanding of the process to determine root case and coordinate resolution of complaints.
  • Completes more complex customer questionnaires
  • Ability to work with contract manufacturers and ensure Client and regulatory requirements are fully met.
  • SAP ( or other ERP ) experience an asset.

Principal Responsibilities

  • Manage customer complaint process, Non-Conformance Management (NCM), process with investigators and work with Legal to develop customer letter for product quality NCMS as appropriate.
  • Develop updated NCM system training and provide the businesses guidance on trends and opportunities for improvement and insight to customer expectations.
  • Provide FDA with NCM review, as needed.
  • Work with EHS Management Systems (Responsible Care Management System RCMS)
  • Conduct training for the business, customer care, and manufacturing sites concerning QM/EHS related topics
  • Advise on the North American Kosher and Halal programs, as appropriate
  • Provide QA oversight for warehousing activities - disposition, relabeling, repackaging and damage material disposal
  • Oversee testing and final release of tolled or contract manufactured materials. Includes traveling to tollers during production runs as needed.
  • Direct experience writing site and division level processes and procedures (have basic knowledge of laboratory practices at sites)
  • Label and technical document approval responsibilities, specifically for contract and tolled materials
  • Act as the Manufacturing Site's QA Liaison
  • Interact with global for labels on imported products and drive disposition decisions

If interested; kindly share your updated resume with answers:
Q1: Which year you have completed your Bachelors and in which discipline
Q2: How many years of exp Quality Auditor working with Internal Quality control. Internal auditor with IATF/ISO certification
Q3: How many years of Auditing Experience IATF 16949/ ISO 9001 VDA 6.3 preferred
Q4: How many years of ex in Managing customer complaint process, Non-Conformance Management (NCM), process with investigators and work with Legal to develop customer letter for product quality NCMS as appropriate.
Q5. How far you live and how will you commute daily to 1609 Biddle Avenue, Wyandotte MI