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Engineering - Senior Engineer, Quality Assurance Engineering - Individual Contr

IntePros

New York, New York • Today

Full-time

USD 50.00 - 52.00 per hour

Senior Engineer, Quality Assurance Engineering

Judge Group, Inc.

Mahwah, New Jersey • Today

Contract

USD 55.00 - 63.00 per hour

Senior Quality Assurance Engineer

Spruce Technology Inc.

Queens, New York • 19d ago

Easy Apply

Contract

Depends on Experience

Senior Quality Engineer

Genesis10

Mahwah, New Jersey • 28d ago

Easy Apply

Full-time

USD 51.91 - 61.91 per hour

Senior Quality Engineer

Robinhood

New York, New York • 5d ago

Full-time

USD 153,000.00 - 180,000.00 per year

Senior Engineer

City of New York

New York, New York • Today

Full-time

USD 100,000.00 - 125,000.00 per year

Senior Engineer

Salas O'Brien Engineers Incorporated

Remote • Today

Full-time

USD 99,750.00 - 115,500.00 per year

Senior Engineer

Motional

Remote or Pittsburgh, Pennsylvania • Today

Full-time

USD 168,121.00 - 214,200.00 per year

Senior Engineer

PeopleTec, Inc.

Remote or Huntsville, Alabama • Today

Full-time

Senior Quality Engineer Tester

AIT Global, Inc.

Remote • Today

Easy Apply

Contract

Senior Engineer

City of Durham, Technology Solutions Dept.

Remote or Durham, North Carolina • Today

Full-time

USD 79,058.00 - 122,536.00 per year

Senior Engineer

FANUC America Corporation

Montville, New Jersey • Today

Full-time

USD 83,716.00 - 135,062.00 per year

Job Details

Skills

CONTR
Healthcare Information Technology
Regulatory Compliance
PPAP
Change Control
Documentation
Process Control
Process Improvement
Testing
Inspection
Quality Improvement
Biomedical Engineering
Mechanical Engineering
Quality Assurance
Change Management
Quality Management
QMS
Conflict Resolution
Problem Solving
Analytical Skill
Critical Thinking
Audio Engineering
Communication
Attention To Detail
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Management
Supervision
Medical Devices
ISO 13485
GDP
GMP

CONTR
Healthcare Information Technology
Regulatory Compliance
PPAP
Change Control
Documentation
Process Control
Process Improvement
Testing
Inspection
Quality Improvement
Biomedical Engineering
Mechanical Engineering
Quality Assurance
Change Management
Quality Management
QMS
Conflict Resolution
Problem Solving
Analytical Skill
Critical Thinking
Audio Engineering
Communication
Attention To Detail
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Management
Supervision
Medical Devices
ISO 13485
GDP
GMP

Summary

Senior Quality Engineer - EU MDR
Location: Northern NJ / Rockland County, NY area
Hybrid - 3 days a week on site
About the Opportunity
IntePros is partnering with a leading global medical technology company to find a Senior Quality Engineer for its EU MDR compliance work. You'll provide quality engineering support across operations and other business functions for a portfolio of medical devices. That means making sure products meet regulatory requirements, are free of defects, and work as designed.
This is a remote, independent role for an experienced quality engineer. You'll act as the voice of Quality across cross-functional, multi-site teams.
What You'll Do

Support EU MDR initiatives for an assigned product portfolio.
Develop, execute, and approve First Article Inspection (FAI) strategies.
Support the Production Part Approval Process (PPAP).
Lead change control activities and change impact assessments.
Update and review SOPs and risk documentation.
Support equipment and process validations.
Develop and implement methods for process control, process improvement, testing, and inspection.
Lead quality improvement initiatives and keep work compliant with applicable regulations and standards.

What You Bring

A bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering field (required).
4+ years of industry experience in quality engineering.
2+ years supporting EU MDR programs or initiatives.
Knowledge of change management and Quality Management System (QMS) principles.
Strong problem-solving, analytical, and critical thinking skills, and the ability to make sound engineering decisions on your own.
Excellent written and verbal communication skills and close attention to detail.
Proficiency in Microsoft Word, Excel, and PowerPoint.
The ability to manage multiple priorities in a fast-paced environment with minimal supervision.
A collaborative, stakeholder-focused approach and the ability to build trust across teams.

Nice to Have

Medical device industry experience.
Familiarity with ISO 13485, EU regulations, GDP, and GMP.
Knowledge of risk-based and statistical methods.

Additional Details

Fully remote, with up to 10% travel.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10488758
Position Id: f9be3b1972ed31dc214d71fd13cc5707
Posted 3 hours ago

Fitment

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Similar Jobs

Senior Quality Engineer

Mahwah, New Jersey

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28d ago

Genesis10 is currently seeking a Senior Quality Engineer for a contract position with a Global Medical Technology Company located in Mahwah, NJ. This is a 12+ month contract opportunity. As a Senior Quality Engineer, you will provide quality engineering support in quality assurance, control, and preventative activities within operations and other business functions. This individual contributor role requires developing and implementing methods for process control, improvement, testing, and inspec

Easy Apply

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Senior Engineer, Quality Assurance Engineering

Mahwah, New Jersey

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Location: Mahwah, NJ Salary: $55.00 USD Hourly - $63.00 USD Hourly Description: Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 12 month + contract. Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements. HYBRID - 3 days or more onsite As a Senior Quality Engineer you will provide quality engineering support in quality assurance, control and preventative activities within operations and other busi

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Engineer, Quality Assurance

Mahwah, New Jersey

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Location: Mahwah, NJ Salary: $41.00 USD Hourly - $43.00 USD Hourly Description: Title: Engineer, Quality Assurance Location: Mahwah, NH Duration: 12+ Month Contract About the Role As a Quality Engineer you will provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions. You will be tasked with developing and implementing methods and procedures for process control, process improvement, testing and inspection to

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Validation Engineer

Fairfield, New Jersey

•

Today

Job Type Full-time Description Join Weiss-Aug - A Leader in Precision Manufacturing and Innovation Be part of a company that's shaping the future of manufacturing where your ideas, skills, and passion matter. Weiss-Aug, is a leading provider of advanced manufacturing and engineering solutions with advanced facilities across the U.S. and Mexico for over 50 years. Why Join Us? At Weiss-Aug we are driven by a commitment to excellence, innovation, and continuous improvement. As a recognized le

Full-time

USD 100,000.00 - 110,000.00 per year

Job Details

Skills

CONTR
Healthcare Information Technology
Regulatory Compliance
PPAP
Change Control
Documentation
Process Control
Process Improvement
Testing
Inspection
Quality Improvement
Biomedical Engineering
Mechanical Engineering
Quality Assurance
Change Management
Quality Management
QMS
Conflict Resolution
Problem Solving
Analytical Skill
Critical Thinking
Audio Engineering
Communication
Attention To Detail
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Management
Supervision
Medical Devices
ISO 13485
GDP
GMP

CONTR
Healthcare Information Technology
Regulatory Compliance
PPAP
Change Control
Documentation
Process Control
Process Improvement
Testing
Inspection
Quality Improvement
Biomedical Engineering
Mechanical Engineering
Quality Assurance
Change Management
Quality Management
QMS
Conflict Resolution
Problem Solving
Analytical Skill
Critical Thinking
Audio Engineering
Communication
Attention To Detail
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Management
Supervision
Medical Devices
ISO 13485
GDP
GMP

Summary

Support EU MDR initiatives for an assigned product portfolio.
Develop, execute, and approve First Article Inspection (FAI) strategies.
Support the Production Part Approval Process (PPAP).
Lead change control activities and change impact assessments.
Update and review SOPs and risk documentation.
Support equipment and process validations.
Develop and implement methods for process control, process improvement, testing, and inspection.
Lead quality improvement initiatives and keep work compliant with applicable regulations and standards.

What You Bring

A bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering field (required).
4+ years of industry experience in quality engineering.
2+ years supporting EU MDR programs or initiatives.
Knowledge of change management and Quality Management System (QMS) principles.
Strong problem-solving, analytical, and critical thinking skills, and the ability to make sound engineering decisions on your own.
Excellent written and verbal communication skills and close attention to detail.
Proficiency in Microsoft Word, Excel, and PowerPoint.
The ability to manage multiple priorities in a fast-paced environment with minimal supervision.
A collaborative, stakeholder-focused approach and the ability to build trust across teams.

Nice to Have

Medical device industry experience.
Familiarity with ISO 13485, EU regulations, GDP, and GMP.
Knowledge of risk-based and statistical methods.

Additional Details

Fully remote, with up to 10% travel.

Dice Id: 10488758
Position Id: f9be3b1972ed31dc214d71fd13cc5707
Posted 3 hours ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Senior Quality Engineer

Mahwah, New Jersey

•

28d ago

Easy Apply

Full-time

USD 51.91 - 61.91 per hour

Senior Engineer, Quality Assurance Engineering

Mahwah, New Jersey

•

Today

Contract

USD 55.00 - 63.00 per hour

Engineer, Quality Assurance

Mahwah, New Jersey

•

Today

Contract

USD 41.00 - 43.00 per hour

Validation Engineer

Fairfield, New Jersey

•

Today

Full-time

USD 100,000.00 - 110,000.00 per year