Senior Quality Engineer

Job Summary

Joining a collaborative team, the full-time Senior Quality Engineer will provide design assurance support for medical devices, ensuring compliance with regulations and standards while participating in cross-functional projects related to product development and risk management.

Key responsibilities

• Represent Quality initiatives on design and development project teams, ensuring compliance during reviews
• Evaluate and approve design control documentation to maintain adherence to external standards and internal procedures
• Own risk management activities for device systems, including developing risk management plans and conducting hazard analyses

Required qualifications

• Bachelor's Degree in Engineering or Science, or equivalent work experience
• A minimum of five years of experience in a medical device environment
• Strong knowledge of ISO 13485, ISO 14971, and Quality System Regulations related to design control and risk management
• Experience with statistical analysis and quality control processes
• Proficiency in MS Office applications and statistical software