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Barrington James · 1 day ago

Quality Design Assurance Engineer

Houston, TX

Full-time

Hybrid

Mid Level

4+ years exp

Barrington James is a global Medical Device company, experiencing exponential growth in the US. They are looking for a solution-oriented Quality Design Assurance Engineer with a strong background in robotic-assisted surgery systems to join their growing team.

Health CareRecruiting

Hiring Manager

Aida Shabani

Responsibilities

Oversee and ensure the implementation of design controls throughout the product development process, including design inputs, outputs, verification, and validation in alignment with FDA 21 CFR 820 and ISO 13485 standards

Qualification

Quality AssuranceDesign AssuranceRobotic-assisted surgeryRegulatory requirementsCommunication skillsInterpersonal skills

Required

4+ years of experience in Quality Assurance or Design Assurance within the medical device industry, with specific experience in robotic-assisted surgery systems

Excellent communication and interpersonal skills with the ability to work effectively with cross-functional teams

Solid understanding of regulatory requirements, including FDA 21 CFR 820, ISO 13485, ISO 14971, and clinical trial requirements