Quality Compliance Engineer, Medical Devices & CAPA Lead

PROCEPT BioRobotics Corporation; San Jose (CA); On-site; USD 140,000 - 170,000; Full time

Job summary

PROCEPT BioRobotics Corporation in the San Jose area seeks a Staff Quality Engineer to lead quality compliance, CAPA, and post-market surveillance initiatives within a fast-paced medical device environment. You will partner with cross-functional teams to strengthen the Quality System and ensure regulatory alignment.

The role requires 8 years in medical devices with 5+ years in quality systems/compliance, and hands-on experience with FDA QSR/QMSR, ISO 13485, MDSAP, and EU MDR, plus strong

Qualifications

• Bachelor’s degree in engineering, science, or another technical discipline.
• 8 years of progressive experience in medical device industry, including at least 5 years in quality systems, quality engineering, and/or compliance roles.
• Working knowledge of FDA QSR/QMSR, ISO 13485, MDSAP, and EU MDR regulatory requirements.
• Experience leading project teams and delivering results within aggressive timelines.

Responsibilities

• Lead and manage Quality Compliance and Post-Market Surveillance projects.
• Identify process risks and drive sustainable improvements in the QMS.
• Perform CAPAs including root cause investigations and corrective actions.
• Define key performance metrics and monitor effectiveness of processes.
• Collaborate with cross-functional stakeholders to meet project objectives.

Skills

CAPA process

Root cause analysis

QMS knowledge

Regulatory compliance

Data analysis

Cross-functional collab

Education

Bachelor’s degree in engineering/science/technical

Master’s degree (preferred)

Job description

PROCEPT BioRobotics Corporation in the San Jose area seeks a Staff Quality Engineer to lead quality compliance, CAPA, and post-market surveillance initiatives within a fast-paced medical device environment. You will partner with cross-functional teams to strengthen the Quality System and ensure regulatory alignment.

The role requires 8 years in medical devices with 5+ years in quality systems/compliance, and hands-on experience with FDA QSR/QMSR, ISO 13485, MDSAP, and EU MDR, plus strong