Description
The Quality Engineer will support product leadership and risk management for new product development and sustaining activities of combination products. Responsibilities include leading risk assessments, test methods, component qualifications, design and process validation, product investigations, manufacturing control plans, regulatory technical submissions, supplier audits, and cross-functional project activities. The role requires a BS in Engineering, at least five years of engineering or quality engineering experience in the medical device, pharmaceutical, or equivalent industry, and preferably pharmaceutical or combination product experience. The primary work location is Tempe, Arizona, United States, with approximately 25% travel.
