Quality Compliance Engineer - CAPA & Post-Market Lead

PROCEPT BioRobotics; San Jose (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

PROCEPT BioRobotics is seeking a Staff Quality Engineer, Quality Compliance to lead initiatives that improve the Quality Management System and Post‑Market Surveillance processes. You will drive CAPA, monitor key quality metrics, and partner with cross‑functional teams to raise performance and compliance.

Ideal candidates have 8 years in medical device quality roles, deep regulatory knowledge (FDA QSR/QMSR, ISO 13485, MDSAP, EU MDR), and strong problem‑solving and communication skills.

Qualifications

• Bachelor’s degree in engineering, science, or another technical discipline.
• 8 years of progressive experience in a 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.
• Working knowledge of computer software validation principles, including in-device software, GxP systems, and 21 CFR Part 11.
• Demonstrated ability to lead project teams and deliver results within aggressive timelines.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to clearly convey complex concepts to diverse audiences.
• Ability to travel up to 10% as required.

Responsibilities

• Lead and manage special projects for the Quality Compliance and Post-Market Surveillance team, including planning, execution, and delivery of strategic initiatives and continuous improvement efforts.
• Proactively identify process risks and improvement opportunities within the Quality Management System (QMS), leveraging a deep understanding of cross-functional interdependencies to implement sustainable, effective solutions.
• Serve as a Quality Compliance and Post-Market Surveillance team representative on cross-functional initiatives, operating independently while influencing stakeholders and coordinating activities to meet project objectives.
• Perform and lead Corrective and Preventive Actions (CAPA), including conducting thorough root cause investigations and developing corrective actions with appropriate scope and rigor relative to the identified quality issue.
• Define key performance requirements for processes and projects; establish monitoring mechanisms and evaluate effectiveness against defined objectives to ensure continuous improvement.
• Review and interpret regulations, standards, and guidance to ensure products, processes, and services remain compliant and aligned with state-of-the-art and regulatory expectations.
• Apply sound technical judgment, data-driven analysis, and pragmatic problem-solving within the constraints of applicable regulations, standards, and internal procedures.
• Drive cross-functional collaboration by effectively engaging subject matter experts and stakeholders to achieve aligned, timely outcomes.
• Demonstrate leadership through technical competence, influence, accountability, and independent decision-making, without direct people management responsibility.
• Maintain trained status and comply with the PROCEPT BioRobotics Quality Management System (QMS) and EHS policies.
• Perform other duties as assigned.

Skills

Regulatory compliance

Quality systems

CAPA and root cause analysis

Project leadership

Analytical skills

Cross-functional collaboration

Written and verbal communication

Travel readiness

Education

Bachelor’s degree in engineering, science, or another technical discipline

Master’s degree in engineering, science, or another technical discipline

Tools

FDA QSR/QMSR

ISO 13485

MDSAP

EU MDR

21 CFR Part 11

Job description

PROCEPT BioRobotics is seeking a Staff Quality Engineer, Quality Compliance to lead initiatives that improve the Quality Management System and Post‑Market Surveillance processes. You will drive CAPA, monitor key quality metrics, and partner with cross‑functional teams to raise performance and compliance.

Ideal candidates have 8 years in medical device quality roles, deep regulatory knowledge (FDA QSR/QMSR, ISO 13485, MDSAP, EU MDR), and strong problem‑solving and communication skills.