Quality Engineer II – Design, Reliability Assurance

Integra LifeSciences

Design Quality Assurance Engineer supporting product development and compliance with quality standards in the medical device sector.

Posted 6/19/2026full-timePrinceton • Illinois, Maryland, Massachusetts, New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $71,300 - $97,750 per yearWebsite

About the role

Key responsibilities & impact

Support the design and development of new or improved products
Support Design Reviews, Technical Reviews, and Gate Reviews
Lead and support the execution of all Risk Management and Usability Engineering process activities
Author or review for approval other Risk Management Documentation
Support Internal partners in the development of products
Coordinate, review and approve development documentation created by external partners
Lead implementation of SPC programs with Manufacturing and Quality Control
Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures
Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
Identify and implement opportunities for continuous improvement

Requirements

What you’ll need

Bachelor’s degree in Science, Engineering (Biomedical, Mechanical or Electrical) or related discipline
4+ years of experience in Quality Engineering, process engineering or R&D Engineering for medical device
Proficient in the application of risk management and design control standards and best practices to NPD and LSM
Demonstrates excellent knowledge of statistical sampling and analysis tools/methods
Demonstrated knowledge and understanding of applicable national and international regulations and standards
Demonstrates excellent organizational, verbal and written communication skills
Proficient with the MS Office Suite, and statistical software
Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA)
Knowledge of TrackWise preferred
Knowledge of Agile product lifecycle management system preferred

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
401(k) savings plan

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Engineeringprocess engineeringR&D Engineeringrisk managementdesign controlstatistical samplingstatistical analysisGMPQSRISO

Soft Skills

organizational skillsverbal communicationwritten communication