Quality Engineer II

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