Quality Engineer II

Job Summary

A company is looking for an Engineer II, Design Quality.

Key Responsibilities

• Represent Quality initiatives and compliance on design and development project teams
• Provide guidance for the generation, review, and approval of design control documentation
• Own risk management activities for device systems in compliance with ISO 14971

Required Qualifications

• Bachelor's Degree in Engineering or Science, or equivalent work experience
• A minimum of two years of related experience in a medical device or QMS environment
• Thorough knowledge of Quality System Regulations and international quality system standards
• Experience with statistics and SPC process control
• Strong project management and prioritization skills