Top 247 Quality engineer Jobs in Lisle Il

Regulatory Quality Engineer
ARCH Medical Solutions —Elmhurst, IL
- From $90,310.67 a year
- Full-time
- 5 years
- Mid-level
- US work authorization
- Health savings account
- Health insurance
Quick Apply
11d
Quality Engineer
Socomec, Inc. —Schaumburg, IL
- $75,000 - $80,000 a year
- Full-time
- 5 years
- Engineering
- Mid-level
- Dental insurance
- 401(k)
Quick Apply
4d
Quality Engineer
RTC —Rolling Meadows, IL
- 18 years or older
- Microsoft Excel
- Schematics
- Commuter assistance
- Paid parental leave
Associate Quality Engineer
Zing Recruiting —Bridgeview, IL
- $70,000 - $80,000 a year
- 2 years
- Entry level
Quick Apply
4d
Quality Engineer
Dynomax Inc. —Wheeling, IL
- $80,000 - $120,000 a year
- Full-time
- CAD
- Engineering
- Mid-level
- Paid holidays
- Disability insurance
Quick Apply
6d
Quality Engineer
Fresenius Kabi —Melrose Park, IL
- $80,000 - $110,000 a year
- Full-time
- English
- Mid-level
- Wellness program
- Paid holidays
10d
Quality Engineer I
G&W Electric Co —Bolingbrook, IL
- $62,000 - $82,513 a year
- Full-time
- Organizational skills
- Ability to lift 25 pounds
- Entry level
- Profit sharing
- Disability insurance
Quick Apply
3d
Quality Engineer - Chicago
Photon —Chicago, IL
- $32,000 - $112,000 a year
- Software troubleshooting
- Mid-level
- Paid holidays
- Health insurance
Quality Manager
DRC Heat Transfer —Melrose Park, IL
- Full-time
- Background check
- Management
- Bachelor's degree
- Health savings account
- Health insurance
Quick Apply
Lead System Test Engineer (Audio & Video Solutions)
Shure —Skokie, IL
- $113,000 - $182,000 a year
- Full-time
- Computer Science
- Engineering
- Office
- Health insurance
- Paid time off
Validation Engineer (Computer Systems)
Fresenius Kabi —Melrose Park, IL
- $65,000 - $80,000 a year
- Full-time
- Background check
- English
- Mid-level
- Wellness program
- Paid holidays
Quick Apply
Quality Assurance - Quality Engineer III
Viant Medical —Wheeling, IL
- $95,000 - $115,000 a year
- Full-time
- 7 years
- Engineering
- Senior level
- Paid holidays
- Health insurance
Quick Apply
12d
API Test Engineer - AI Trainer
DataAnnotation —Chicago, IL
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
Accessibility QA Engineer - AI Trainer
DataAnnotation —Chicago, IL
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
QA Specialist
Momentum Staffing Group LLC —Oak Brook, IL
- $60,000 a year
- Mid-level
- Bachelor's degree
Quick Apply
5d
QA Specialist
Momentum Staffing Group LLC —Naperville, IL
- $60,000 a year
- Mid-level
- Bachelor's degree
Quick Apply
10d
Quality Engineer, Site Lead
Ingersoll Rand —Chicago, IL
- $80,000 - $110,000 a year
- Full-time
- Engineering
- 3 years
- US work authorization
- Health insurance
- Dental insurance
Quality Engineer
Dynomax Inc. —Wheeling, IL
- $80,000 - $120,000 a year
- Full-time
- CAD
- Engineering
- Mid-level
- Paid holidays
- Disability insurance
Quick Apply
6d
Senior SDET / Chicago / Python
Motion Recruitment —Chicago, IL
- Full-time
- SQL
- US work authorization
- Senior level
- Health insurance
- Dental insurance
Principal, Software Engineering: Software Development Test (SDET)
Options Clearing Corporation —Chicago, IL
- $158,600 - $263,700 a year
- Full-time
- Hybrid work
- Computer science
- 7 years
- Computer Science
- Health insurance
- Dental insurance

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quality engineer jobs near lisle il

Regulatory Quality Engineer

ARCH Medical Solutions -
Elmhurst, IL

Quick Apply

Job Details

Full-time
From $90,310.67 a year
11 days ago

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching
Professional development assistance
Life insurance

Qualifications

Medical device testing
ISO standards
Mechanical Engineering
Biomedical Engineering
GD&T
Manufacturing facility experience
Production validation processes
ASME codes & standards
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Process management

Full Job Description

ARCH Medical Solutions – MedTorque is seeking an experienced Regulatory Quality Engineer. This position may be based at either our Elmhurst, Illinois or Kenosha, Wisconsin facility and is responsible for supporting quality system and regulatory compliance activities across both medical device manufacturing locations.

The Regulatory Quality Engineer serves as the Quality System Management Representative and plays a key role in ensuring compliance with FDA regulations, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements. This position is responsible for maintaining and enhancing the effectiveness of the Quality Management System (QMS), leading quality system initiatives, supporting audits and inspections, and driving continuous improvement efforts. Working closely with cross-functional teams, the Regulatory Quality Engineer helps ensure product quality, regulatory compliance, and operational excellence throughout the organization.

Key Responsibilities

Serve as the Quality System Management Representative for both manufacturing facilities.
Establish, implement, maintain, and continuously improve Quality Management System (QMS) processes and procedures.
Promote awareness of regulatory and quality system requirements and provide training to employees.
Maintain FDA Establishment Registrations and Device Listings and serve as a direct liaison with the FDA.
Support and lead activities related to: Engineering Change Orders (ECOs), Corrective and Preventive Actions (CAPAs), Material Review Board (MRB) processes, Risk Management, Nonconformance investigations, Corrective action effectiveness verification
Plan, conduct, and manage supplier, internal, customer, regulatory, and process audits, including documentation and follow-up activities.
Establish and maintain validation programs, including coordination of manufacturing process validations.
Develop and monitor quality metrics and key performance indicators.
Collaborate with suppliers, customers, and cross-functional teams to resolve quality and compliance issues.
Support regulatory inspections and customer audits.
Drive continuous improvement initiatives to enhance product quality, compliance, and operational effectiveness.

Qualifications Required

Bachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering is strongly preferred or equivalent,
or five to ten years of experience in medical device manufacturing industry and in the quality engineering role, and/or training,
or equivalent combination of education and experience.
Knowledge of the medical device manufacturing industry.
Strong regulatory background in medical device manufacturing.
Strong knowledge of EU MDR and MDSAP requirements.
Knowledge of FDA 21 CFR Part 820 and ISO 13485 Quality Management System requirements.
Knowledge of Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5.
Familiarity with test methods and standards used for medical device design verification and validation.
U.S. citizenship required.

Pay: $90,310.67 - $93,110.79 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Professional development assistance
Tuition reimbursement
Vision insurance

Application Question(s):

Have you ever been a primary contact during an FDA inspection or regulatory audit?

Do you have experience with FDA 21 CFR Part 820 and ISO 13485?

Experience:

quality and regulatory compliance: 5 years (Required)

Work Location: In person

Quick Apply

Refine Your Search

quality engineer jobs in lisle il

Regulatory Quality Engineer

Quality Engineer

Quality Engineer

Associate Quality Engineer

Quality Engineer

Quality Engineer

Quality Engineer I

Quality Engineer - Chicago

Quality Manager

Lead System Test Engineer (Audio & Video Solutions)

Validation Engineer (Computer Systems)

Quality Assurance - Quality Engineer III

API Test Engineer - AI Trainer

Accessibility QA Engineer - AI Trainer

QA Specialist

QA Specialist

Quality Engineer, Site Lead

Quality Engineer

Senior SDET / Chicago / Python

Principal, Software Engineering: Software Development Test (SDET)

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