Quality Engineer II – Design, Reliability Assurance

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

• 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 Track Wise preferred
• Knowledge of Agile product lifecycle management system preferred