Quality Assurance and Regulatory Affairs Engineer — Medical Devices

Job overview

The Quality Assurance and Regulatory Affairs Engineer — Medical Devices role is onsite in Reno, NV, with annual compensation of $80,000–$110,000. The role supports OMEC Medical’s medical-device portfolio, from hand-held instruments to surgical robotics systems. The engineer establishes and maintains the quality management system and provides quality and regulatory support across product development, commercialization, and post-market activities. This work helps ensure devices meet FDA, EU MDR, and applicable international requirements while supporting product safety and timely development.

What you'll do

• Design, implement, and improve the medical-device quality management system
• develop and maintain procedures, policies, work instructions, SOPs, and technical documentation
• support new product introduction and design controls
• identify and manage quality risks
• lead or contribute to regulatory submissions
• support audits, validation, supplier qualification, and post-market surveillance
• collaborate with cross-functional teams.

What we're looking for

Skills & competencies

quality assurance

regulatory affairs

medical devices

quality engineer

reno nv

resourcing edge

full-time

fda 510(k)

iso 13485

eu mdr

design controls

supplier quality

post-market surveillance

Work arrangement

• Weekend coverage required

Why this role

The posting seeks 4–7 years of medical-device quality/regulatory engineering experience and experience with FDA 510(k) submissions and regulatory audits. Conversational Mandarin and experience with Class III devices or surgical robotics are beneficial.

About the employer

Resourcing Edge is hiring for this role. Industry: Surgical and Medical Instrument Manufacturing. Sector: 33.