IntePros
IntePros

Engineering - Senior Engineer, Quality Assurance Engineering - Individual Contr

New York, NY, US • Posted 2 hours ago • Updated 2 hours ago
Full Time
On-site
USD $50.00 - 52.00 per hour
Fitment

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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

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 2 hours ago
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