Quality Compliance Engineer Job Headquarters Idaho USA,Engineering

Position: Staff Quality Compliance Engineer
Location: Headquarters

Overview

PROCEPT Bio Robotics focuses on patient-first innovation in surgical robotics to treat benign prostatic hyperplasia (BPH). The company emphasizes a culture of curiosity, humility, and engagement, offering programs to support leadership development and cross-functional teamwork. This overview reflects the organization’s mission and commitment to people and career growth.

The Opportunity That Awaits You

Reporting to the Senior Director, Global Quality Compliance and Post-Market Surveillance (PMS), the Staff Quality Engineer, Quality Compliance will lead actions to improve the compliance, effectiveness, and efficiency of processes within Quality Compliance and PMS. The role represents Quality Compliance and PMS with internal stakeholders and process owners, develops and implements quality tools to monitor key metrics, and identifies opportunities for continuous improvement to scale workflows for evolving business needs.

Your

Day-to-Day

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 opportunities within the Quality Management System (QMS), leveraging cross-functional interdependencies to implement sustainable solutions.

Serve as a Quality Compliance and PMS representative on cross-functional initiatives, operating independently while influencing stakeholders and coordinating activities to meet objectives.

Perform and lead Corrective and Preventive Actions (CAPA), including root cause investigations and development of corrective actions with appropriate scope and rigor.

Define key performance requirements for processes and projects; establish monitoring mechanisms and evaluate effectiveness against objectives to ensure continuous improvement.

Review and interpret regulations, standards, and guidance to ensure products, processes, and services remain compliant with regulatory expectations.

Apply sound technical judgment, data-driven analysis, and pragmatic problem-solving within regulatory and internal procedures.

Drive cross-functional collaboration by engaging subject matter experts and stakeholders to achieve aligned outcomes.

Demonstrate leadership through technical competence, accountability, and independent decision-making, without direct people management responsibility.

Maintain trained status and comply with the PROCEPT Bio Robotics Quality Management System (QMS) and EHS policies.

Perform other duties as assigned.

Qualifications We Need You to Possess

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 apply conceptual and systems thinking to understand complex issues and downstream implications.
Proven ability to collaborate effectively in a fast-paced, matrixed environment.
Ability to travel up to 10% as required.

Qualifications We Prefer You to Possess

Master’s degree in engineering, science, or another technical discipline.
Prior supervisory or managerial experience.

Pay Range for this role: $144,320 to $169,790

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