Senior Quality Compliance Engineer (Medical Devices)

BioRobotics; California (MO); On-site; USD 144,320 - 169,790; Full time

Job summary

PROCEPT BioRobotics in California is seeking a Staff Quality Engineer to lead initiatives focused on Quality Compliance and Post-Market Surveillance. The ideal candidate will have at least 8 years of experience in the medical device industry, including strong knowledge of regulatory standards such as FDA QSR and ISO 13485.

This role involves managing projects, improving quality compliance processes, and driving cross-functional collaboration. The position offers a competitive salary range of $144,320 to $169,790.

Qualifications

• 8 years of experience in the medical device industry, with at least 5 years in quality systems or engineering.
• Proven ability to lead project teams and deliver timely results.
• Strong analytical and organizational skills with excellent communication.

Responsibilities

• Lead projects for Quality Compliance and Post-Market Surveillance.
• Identify process risks and implement solutions.
• Conduct root cause investigations and develop corrective actions.

Skills

Quality Management System

Regulatory Compliance

Analytical Skills

Problem-Solving

Communication Skills

Education

Bachelor's degree in engineering or science

Tools

FDA QSR/QMSR Regulations

ISO 13485

GxP Systems

Job description

PROCEPT BioRobotics in California is seeking a Staff Quality Engineer to lead initiatives focused on Quality Compliance and Post-Market Surveillance. The ideal candidate will have at least 8 years of experience in the medical device industry, including strong knowledge of regulatory standards such as FDA QSR and ISO 13485.

This role involves managing projects, improving quality compliance processes, and driving cross-functional collaboration. The position offers a competitive salary range of $144,320 to $169,790.