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Senior Quality Engineer - Disposables at PROCEPT BioRobotics - ApplyBlast

Senior Quality Engineer - Disposables

PROCEPT BioRobotics

6 months ago

3.6 on Glassdoor

San Jose, CA

Onsite

Full Time

Senior

0 applicants

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About this role

A Senior Quality Engineer at PROCEPT BioRobotics ensures quality, reliability, and scalability of single-use products and accessory components from development through commercialization. The role involves cross-functional collaboration with R&D, Manufacturing, Regulatory, and Supply Chain teams to establish and maintain robust quality systems in compliance with FDA QSR, ISO 13485, and EU MDR.

Skills

Qualifications

BS in Engineering, Microbiology, Life Sciences, or related technical field (MS preferred)Minimum 5+ years of experience in medical device industry (class II medical devices preferred)Direct experience working with surgical instruments, electromechanical devices, or surgical accessories is highly preferredStrong understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDRProficient in statistical methods and tools such as Minitab to support validation and quality decisions

About PROCEPT BioRobotics

procept-biorobotics.com

Headquarters

San Jose, California, United States

Company Size

201-500 employees

Founded

2009

View Profile

PROCEPT BioRobotics is a surgical robotics company focused on advancing patient care in urology, particularly treatments that improve men’s health. The company develops and commercializes robotic solutions such as Aquablation Therapy (AquaBeam Robotic System) and the HYDROS Robotic System to give surgeons greater precision, reproducibility, and safety. PROCEPT emphasizes clinical evidence, provider resources, training, and reimbursement support to drive adoption in hospitals and practices. Their offerings aim to modernize urologic procedures and improve outcomes for patients and clinicians.