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Senior Design Quality Engineer at Caris Life Sciences - ApplyBlast

Senior Design Quality Engineer

Caris Life Sciences

5 months ago

3.3 on Glassdoor

Phoenix, AZ

Onsite

Full Time

Senior

0 applicants

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About this role

A Senior Design Quality Engineer supports Design Controls, risk management, and maintains the Design history file, ensuring compliance with regulations and partnering with cross-functional teams throughout the product lifecycle.

Responsibilities

Create and maintain Design and Development Plan for new development projects
Create and maintain risk management file with support from cross-functional teams
Review and approve DHF deliverables including V&V Plan/Protocol/Reports
Manage deviation and issues for verification and validation activities
Support design reviews and design transfer activities including process validations

Skills

Qualifications

Bachelor’s degree in engineering, scientific or related fieldMinimum 4+ years of hands-on experienceWorking knowledge of design controls, risk management and product development processesExperience with ISO 13485, CFR Part 820, ISO 14971Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems