Quality Specialist
Wyandotte, MI · On-site
$26/hr
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 ...
Wyandotte, MI · On-site
$26/hr
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 ...
Wyandotte, MI · On-site
$26/hr
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 ...
Wyandotte, MI · On-site
$26/hr
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 ...
Wyandotte, MI · On-site
$26/hr
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
$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
Plainwell, MI · On-site
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 ...
Plainwell, MI · On-site
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 ...
Internal Auditor Certified (GFSI Scope) * PCQI Certified * HACCP Certified * Knowledge of BRCGS ... Deep understanding of food safety regulations (FDA, HACCP, MDARD etc.). * Quality Assurance ...
Caledonia, MI · On-site
... 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 ...
Caledonia, MI · On-site
... 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 ...
Grand Rapids, MI · On-site
$90 - $120/hr
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
Grand Rapids, MI · On-site
$90 - $120/hr
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
Operating in a medical device manufacturing environment with FDA and ISO regulatory obligations and ... The Security Engineer - GRC plays a critical role in AirLife's ability to satisfy external auditors ...
Operating in a medical device manufacturing environment with FDA and ISO regulatory obligations and ... The Security Engineer - GRC plays a critical role in AirLife's ability to satisfy external auditors ...
Grand Rapids, MI · On-site
$115K - $130K/yr
Operating in a medical device manufacturing environment with FDA and ISO regulatory obligations and ... The Security Engineer - GRC plays a critical role in AirLife's ability to satisfy external auditors ...
Quick apply
Grand Rapids, MI · On-site
$115K - $130K/yr
Operating in a medical device manufacturing environment with FDA and ISO regulatory obligations and ... The Security Engineer - GRC plays a critical role in AirLife's ability to satisfy external auditors ...
Grand Rapids, MI · On-site
$115 - $130/hr
Operating in a medical device manufacturing environment with FDA and ISO regulatory obligations and ... The Security Engineer - GRC plays a critical role in AirLife's ability to satisfy external auditors ...
Grand Rapids, MI · On-site
$115 - $130/hr
Operating in a medical device manufacturing environment with FDA and ISO regulatory obligations and ... The Security Engineer - GRC plays a critical role in AirLife's ability to satisfy external auditors ...
Newport, MI · On-site
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 ...
Newport, MI · On-site
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 ...
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 ...
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 ...
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 ...
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 ...
Grand Blanc, MI · On-site
... FDA, OHRP, HIPAA, and GCP requirements and guidelines. In addition, this position provides ... Responsible for developing and implementing a comprehensive clinical research compliance auditing ...
Grand Blanc, MI · On-site
... FDA, OHRP, HIPAA, and GCP requirements and guidelines. In addition, this position provides ... Responsible for developing and implementing a comprehensive clinical research compliance auditing ...
Grand Blanc, MI · On-site
... FDA, OHRP, HIPAA, and GCP requirements and guidelines. In addition, this position provides ... Responsible for developing and implementing a comprehensive clinical research compliance auditing ...
Grand Blanc, MI · On-site
... FDA, OHRP, HIPAA, and GCP requirements and guidelines. In addition, this position provides ... Responsible for developing and implementing a comprehensive clinical research compliance auditing ...
Kentwood, MI · On-site
$90 - $135/hr
... FDA-regulated facilities. This position ensures designated sites consistently meet regulatory ... SQF Practitioner or BRC Internal Auditor (preferred) * Work is primarily done in an office setting.
New
Kentwood, MI · On-site
$90 - $135/hr
... FDA-regulated facilities. This position ensures designated sites consistently meet regulatory ... SQF Practitioner or BRC Internal Auditor (preferred) * Work is primarily done in an office setting.
New
Grand Blanc, MI · Hybrid
... FDA, OHRP, HIPAA, and GCP requirements and guidelines. In addition, this position provides ... Responsible for developing and implementing a comprehensive clinical research compliance auditing ...
Grand Blanc, MI · Hybrid
... FDA, OHRP, HIPAA, and GCP requirements and guidelines. In addition, this position provides ... Responsible for developing and implementing a comprehensive clinical research compliance auditing ...
Canton, MI · On-site
... 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 ...
Canton, MI · On-site
... 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 ...
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 ...
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 ...
$28.8K - $35.8K
2% of jobs
$35.8K - $42.8K
17% of jobs
$46.5K is the 25th percentile. Wages below this are outliers.
$42.8K - $49.8K
12% of jobs
$49.8K - $56.8K
11% of jobs
The median wage is $60.5K / yr.
$56.8K - $63.8K
17% of jobs
$63.8K - $70.8K
7% of jobs
$70.8K - $77.8K
6% of jobs
$77.8K - $84.9K
3% of jobs
$85K is the 75th percentile. Wages above this are outliers.
$84.9K - $91.9K
17% of jobs
$91.9K - $98.9K
4% of jobs
$98.9K - $105.9K
4% of jobs
$28.8K
$66.5K
$105.9K
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.
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.
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.
The most popular types of Fda Auditor jobs in Michigan are:
For Fda Auditor jobs in Michigan, the most frequently searched job titles are:
The top searched job categories for Fda Auditor jobs in Michigan are:

$26/hr
Full-time
This job post has expired today. Applications are no longer accepted.
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-
Principal Responsibilities
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
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11 - 50 Employees
Sugar Land, TX, US