Top 759 Validation engineer Jobs in Arlington Heights 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
Engineering Technician
Bowman Analytics —Schaumburg, IL
- $65,000 a year
- Full-time
- Mid-level
- Ability to lift 50 pounds
- Travel
- Paid holidays
- Health insurance
Quick Apply
4d
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
Mid - Level Network Engineer
The LaSalle Network —Buffalo Grove, IL
- $40 - $50 an hour
- Contract
- Azure
- Mid-level
- 3 years
- Dental insurance
- Vision insurance
Quick Apply
5d
Senior Software Engineer
Contemporary Control Systems, Inc. —Downers Grove, IL
- $117,600 - $135,000 a year
- Full-time
- Computer science
- Computer Science
- Software troubleshooting
- AD&D insurance
- Disability insurance
Quick Apply
Validation / Verification Engineer (Contract) (x2)
Farsak —Chicago, IL
- Contract
- Mid-level
- Analysis skills
- Software development
Validation Engineer
Fresenius Kabi —Melrose Park, IL
- $65,000 - $80,000 a year
- Full-time
- Computer literacy
- English
- Mid-level
- Wellness program
- Paid holidays
5d
Quality Engineer
Fresenius Kabi —Melrose Park, IL
- $80,000 - $110,000 a year
- Full-time
- English
- Mid-level
- Wellness program
- Paid holidays
10d
RF Validation and Test Engineer
Tagore Tech —Arlington Heights, IL
- $90,000 - $115,000 a year
- Full-time
- Data analysis skills
- System design
- Mid-level
- Health savings account
- Health insurance
Quick Apply
10d
Validation Engineer (CQV, GMP, Life Sciences)
VBB —Chicago, IL
- $70,000 - $100,000 a year
- Full-time
- 5 years
- Engineering
- Travel
Quick Apply
Validation Engineer
Haumiller Engineering Co —South Elgin, IL
- $73,000 - $95,000 a year
- Full-time
- Mid-level
- 3 years
- Travel
- Health savings account
- AD&D insurance
Quick Apply
Sr Validation Engineer
Morton Grove Pharmaceuticals —Morton Grove, IL
- Full-time
- Mid-level
Quick Apply
Automation Engineer
Gantec Publishing Solutions —Schaumburg, IL
- Full-time
- 6 years
- Computer Science
- SQL
Design Engineer
Terco, Inc. —Bloomingdale, IL
- $80,000 - $100,000 a year
- Full-time
- Background check
- Mid-level
- Travel
- Health insurance
- Dental insurance
Quick Apply
6d
Junior FPGA Engineer
Eagle Seven —Chicago, IL
- From $150,000 a year
- Full-time
- Hybrid work
- Computer Science
- Analysis skills
- APIs
- Commuter assistance
- Health savings account
Quick Apply
Validation Engineer
Katalyst Healthcares & Life Sciences —Round Lake, IL
- Contract
- Hybrid work
- Engineering
- Senior level
- Leadership
Quick Apply
Quality Engineer - Validation
Nemera —Buffalo Grove, IL
- $85,000 - $105,000 a year
- Full-time
- Ability to walk for extended periods
- Computer literacy
- Engineering
- Referral program
Quick Apply
Senior Electrical Engineer IV - Communications
OTTO Engineering —Carpentersville, IL
- $110,000 - $125,000 a year
- Online Application
- Customer service
- Research
- Mentoring
- Profit sharing
- Health savings account
Senior Mechanical Engineer IV - Communications
OTTO Engineering —Carpentersville, IL
- $110,000 - $125,000 a year
- Online Application
- 7 years
- Analysis skills
- Mentoring
- Profit sharing
- Health savings account
Electrical Engineer III - Communications
OTTO Engineering —Carpentersville, IL
- $90,000 - $105,000 a year
- Online Application
- Customer service
- 5 years
- Senior level
- Profit sharing
- Health savings account

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validation engineer jobs near arlington heights 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

validation engineer jobs in arlington heights il

Regulatory Quality Engineer

Engineering Technician

Validation Engineer (Computer Systems)

Mid - Level Network Engineer

Senior Software Engineer

Validation / Verification Engineer (Contract) (x2)

Validation Engineer

Quality Engineer

RF Validation and Test Engineer

Validation Engineer (CQV, GMP, Life Sciences)

Validation Engineer

Sr Validation Engineer

Automation Engineer

Design Engineer

Junior FPGA Engineer

Validation Engineer

Quality Engineer - Validation

Senior Electrical Engineer IV - Communications

Senior Mechanical Engineer IV - Communications

Electrical Engineer III - Communications

I want to receive the latest job alert for validation engineer in arlington heights il

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