Quality Engineer II – Design, Reliability Assurance

Jobtailor; Illinois; On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a Quality Engineer to support risk management, design controls, and regulatory compliance for medical device development. The role involves coordinating with internal teams and external partners to ensure robust documentation and product quality.

You will contribute to design reviews, implement SPC programs with manufacturing, and help drive continuous improvement across GMP, QSR, and ISO frameworks.

Qualifications

• Bachelor’s degree in Science, Engineering (Biomedical, Mechanical, Electrical) or related discipline.
• 4+ years of experience in Quality Engineering, process engineering or R&D Engineering for medical device.
• Proficient in risk management and design control standards for NPD/LSM.
• Knowledge of statistical sampling and analysis tools and methods.
• Familiarity with applicable regulations and standards (FDA, ISO).
• Strong written and verbal communication skills.
• Proficient with MS Office and statistical software.
• Experience with external regulatory audits.

Responsibilities

• Support design and development of new or improved products.
• Support design reviews, technical reviews, and gate reviews.
• Lead and support execution of risk management and usability engineering process activities.
• Author or review risk management documentation for approval.
• Coordinate development documentation with external partners.
• Lead implementation of SPC programs with Manufacturing and Quality Control.
• Develop and implement updates to Quality System procedures.
• Ensure compliance with GMP, QSR, ISO, and other applicable requirements.
• Identify opportunities for continuous improvement.

Skills

Risk management

Design controls

Statistical sampling & analysis

MS Office

Statistical software

FDA/Notified Body audits

Regulatory knowledge

Agile PLM

Communication skills

Education

Bachelor's degree in Science/Engineering

Tools

TrackWise

Agile product lifecycle management system

Job description

Responsibilities

• 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

Qualifications

• 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