Top 138 Quality assurance manager Jobs in Hoffman Estates Il

Engineering Change Control Manager
Hydrox Laboratories —Elgin, IL
- $90,000 - $110,000 a year
- Extended hours
- PMP
- Engineering
- 3 years
- Disability insurance
- Health insurance
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Quality Assurance / Quality Control Manager
Spectra-Tech, Inc. —Hanover Park, IL
- From $75,000 a year
- Full-time
- Management
- Mid-level
- US work authorization
- Health insurance
- 401(k)
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Quality Assurance Manager
Confidential —Chicago, IL
- From $70,000 a year
- Full-time
- Management
- 5 years
- Office
- Health insurance
- Dental insurance
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Quality Manager
DRC Heat Transfer —Melrose Park, IL
- Full-time
- Background check
- Management
- Bachelor's degree
- Health savings account
- Health insurance
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QUALITY ENGINEERING MANAGER
SMALLEY STEEL RING COMPANY —Lake Zurich, IL
- $110,000 - $130,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Mentoring
- Paid holidays
- Disability insurance
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Quality Manager
Associated Fastening Products Inc. —Itasca, IL
- From $80,000 a year
- Full-time
- Microsoft Word
- AutoCAD
- Microsoft Excel
- Disability insurance
- Health insurance
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Manager, Quality & Safety
Fictiv —Schaumburg, IL
- $125,000 - $140,000 a year
- Bachelor of Science
- Engineering
- Travel
- Health insurance
- Dental insurance
Quality Assurance Manager
Kranze Technology Solutions, Inc —Des Plaines, IL
- $100,000 - $150,000 a year
- Full-time
- 5 years
- Office
- Recruiting
- Health savings account
- Health insurance
Senior Quality Operations Manager - Manufacturing
Plexus —Buffalo Grove, IL
- $142,900 - $214,300 a year
- Background check
- Pass drug screening
- Office
- Health insurance
- Dental insurance
Manager, Quality Management
Deloitte —Arlington Heights, IL
- $97,600 - $179,900 a year
- Full-time
- CPA
- 5 years
- Office
4d
Quality Systems Manager
BISCO, Inc. —Schaumburg, IL
- $110,000 - $129,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- 8 years
- Profit sharing
- Disability insurance
12d
Senior Manager, Clinical Quality Assurance
AbbVie —North Chicago, IL
- $124,500 - $236,500 a year
- Full-time
- Hybrid work
- Nursing
- 5 years
- Presentation skills
- Paid holidays
- Health insurance
Manager, Quality
Procoplast —Rolling Meadows, IL
- $135,000 - $160,000 a year
- Overtime
- 5 years
- Engineering
- Analysis skills
- Wellness program
- Disability insurance
Quality Assurance Manager
Bema Incorporated —Saint Charles, IL
- $95,000 - $110,000 a year
- Full-time
- Computer literacy
- Mid-level
- 3 years
- Health insurance
- Dental insurance
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Quality Assurance Manager
AbbVie —North Chicago, IL
- $109,500 - $208,500 a year
- Full-time
- Hybrid work
- 8 years
- Senior level
- Leadership
- Paid holidays
- Health insurance
Manager, Quality
Methode Electronics, Inc. —Rolling Meadows, IL
- $135,000 - $160,000 a year
- Overtime
- 5 years
- Engineering
- Analysis skills
- Wellness program
- Disability insurance
Supplier Quality Manager
Plexus —Buffalo Grove, IL
- $124,200 - $186,400 a year
- Background check
- Google Workspace
- Pass drug screening
- Health insurance
- Dental insurance
Quality Manager
Eaton —Carol Stream, IL
- $113,000 - $165,000 a year
- Full-time
- Background check
- Spanish
- 5 years
- Relocation assistance
- Retirement plan
Manager, Quality Manager - CAPA
Abbott Laboratories —Abbott Park, IL
- $129,300 - $258,700 a year
- Full-time
- Supervising experience
- Training & development
- Senior level
- Health insurance
- Tuition reimbursement
Quality Systems Manager
Chem-Impex International, Inc. —Wood Dale, IL
- $100,000 - $130,000 a year
- Full-time
- Experience equivalent to degree accepted
- Senior level
- Leadership
- Disability insurance
- Health insurance
Quick Apply

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quality assurance manager jobs near hoffman estates il

Engineering Change Control Manager

Hydrox Laboratories -
Elgin, IL

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Job Details

Full-time
$90,000 - $110,000 a year

Benefits

Disability insurance
Health insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Life insurance

Qualifications

Customer communication
Change management
Manufacturing facility experience
Attention to detail
Pharmaceutical company experience
Organizational skills
Quality audits
FDA regulations

Full Job Description

Job Description

The Engineering Change Control Manager oversees and administers the formal change control program for an FDA‑regulated OTC pharmaceutical and cosmetics manufacturing organization. This role ensures that all changes to processes, equipment, materials, documentation, and systems are evaluated, approved, implemented, and verified in compliance with FDA 21 CFR Parts 210/211/330, ISO standards, ICH Q10, and applicable cosmetic regulations. The Change Control Manager acts as the central coordinator between Quality, R&D, Operations, Engineering, Regulatory Affairs, and Supply Chain to maintain a state of control and ensure product quality, safety, and regulatory compliance.

Quality Specific Responsibility

Ensure all operations are conducted in compliance with applicable regulatory requirements, Good Manufacturing Practices (GMP), and company quality standards. All Hydrox Laboratories Supervisors and Managers are responsible for understanding, implementing, updating and maintaining adherence to Standard Operating Procedures (SOPs), ensuring employees follow approved procedures, and promptly addressing or reporting any deviations from established quality or regulatory requirements.

Every leader is accountable for maintaining a culture of quality and ensuring Hydrox standards consistently meet or exceed both internal expectations and customer requirements.

Duties & Responsibilities

· Lead the end‑to‑end change control process, including intake, risk assessment, impact analysis, approval routing, implementation oversight, and closure.

· Ensure all changes comply with FDA, cGMP, OTC monograph, and cosmetic regulatory requirements.

· Facilitate cross‑functional change review board (CRB) meetings and maintain alignment across departments.

· Maintain and continuously improve the Change Control System within the company’s electronic Quality Management System (eQMS).

· Monitor change progress, escalate delays, and ensure timely completion of actions, verifications, and documentation.

· Partner with Regulatory Affairs to determine regulatory filing requirements and ensure appropriate submissions when needed.

· Provide training and guidance to employees on change control procedures and best practices.

· Develop and track KPIs related to change control performance, cycle time, and compliance.

· Support internal and external audits by providing documentation, responding to observations, and implementing corrective actions.

· Ensure changes are properly validated, qualified, or verified according to established protocols.

· Review and evaluate change requests for completeness, accuracy, and regulatory impact.

· Conduct or coordinate risk assessments (e.g., FMEA, hazard analysis) for proposed changes.

· Maintain accurate and compliant documentation within the eQMS.

· Ensure that affected SOPs, batch records, specifications, and quality documents are updated and approved.

· Coordinate with Engineering and Operations to ensure equipment or process changes are properly qualified.

· Verify that training requirements are met before changes go live.

· Prepare reports, metrics, and summaries for management review.

· Support deviation, CAPA, and complaint investigations when changes intersect with quality events.

· Ensure proper archival and traceability of all change control records.

· Works with suppliers and customers to ensure changes are established and communicated for the organization.

Knowledge, Skills and Abilities

· Strong understanding of FDA cGMP regulations (21 CFR 210/211/330) for OTC drug manufacturing.

· Familiarity with cosmetic regulations, including FDA guidelines and international requirements (e.g., EU Cosmetic Regulation).

· Knowledge of ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System).

· Understanding of validation principles (IQ/OQ/PQ), process controls, and quality systems.

· Working knowledge of eQMS platforms and document control systems.

· Awareness of supply chain, manufacturing, and packaging operations in a regulated environment.

· Understanding of risk analysis and application of risk assessment (FMEA)

· Strong analytical and critical‑thinking skills with the ability to assess complex technical changes.

· Excellent communication and facilitation skills to lead cross‑functional teams.

· Ability to interpret and apply regulatory requirements to real‑world manufacturing scenarios.

· High attention to detail and strong organizational skills.

· Ability to manage multiple projects simultaneously and meet deadlines.

· Proficiency in writing clear, concise, and compliant documentation.

· Ability to influence without authority and drive accountability across departments.

· Strong problem‑solving skills with a continuous improvement mindset.

· knowledge of FDA regulations, cGMP, and quality systems.

Qualifications

· Associates or higher degree in Engineering, Chemistry, Pharmaceutical Sciences, Quality Assurance, or a related field (Master’s a plus). Experience will be considered in lieu of degree.

· 3+ years of experience in pharmaceutical, OTC, medical device or cosmetics manufacturing within a regulated environment.

· Experience managing or working within a formal change control system.

· Experience with eQMS platforms (e.g., MasterControl, Veeva, TrackWise, QT9).

· Experience supporting audits (FDA, ISO, customer) strongly preferred.

· Certifications such as ASQ CQA, ASQ CQE, or PMP are a plus.

Working Condition

This position primarily works in an office environment with frequent interaction in manufacturing, engineering, warehouse, laboratory, and packaging areas of an FDA-regulated OTC pharmaceutical and cosmetic manufacturing facility. Regular use of computers, electronic quality management systems (eQMS), document management systems, engineering software, and standard office equipment is required to administer change controls, review technical documentation, and coordinate cross-functional projects.

The position requires frequent sitting, standing, walking, and the ability to move throughout the facility to evaluate equipment, processes, and manufacturing operations, participate in change control assessments, conduct implementation reviews, and collaborate with Quality, Engineering, Operations, Regulatory Affairs, and Supply Chain personnel. Occasional lifting of up to 25 pounds may be required. The employee must be able to perform prolonged computer work and review technical documentation with a high degree of accuracy.

While on the manufacturing floor, the employee is required to wear appropriate personal protective equipment (PPE) and comply with all safety, quality, and Good Manufacturing Practice (GMP) requirements. Exposure to manufacturing noise, chemical odors, varying temperatures, moving machinery, and production activities may occur. The position may require occasional extended hours to support change implementations, equipment qualifications, validation activities, audits, regulatory inspections, or other business needs.

This job description lists the major duties and requirements of the job and is not all-inclusive. Incumbent may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills.

Pay: $90,000.00 - $110,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Health insurance
Life insurance
Paid time off
Tuition reimbursement
Vision insurance

Work Location: In person

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Refine Your Search

quality assurance manager jobs in hoffman estates il

Engineering Change Control Manager

Quality Assurance / Quality Control Manager

Quality Assurance Manager

Quality Manager

QUALITY ENGINEERING MANAGER

Quality Manager

Manager, Quality & Safety

Quality Assurance Manager

Senior Quality Operations Manager - Manufacturing

Manager, Quality Management

Quality Systems Manager

Senior Manager, Clinical Quality Assurance

Manager, Quality

Quality Assurance Manager

Quality Assurance Manager

Manager, Quality

Supplier Quality Manager

Quality Manager

Manager, Quality Manager - CAPA

Quality Systems Manager

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