Staff Quality Compliance Engineer

Company Overview PROCEPT BioRobotics is committed to revolutionizing treatment for benign prostatic hyperplasia (BPH) through surgical robotics innovation. Position Overview Reporting to the Senior Director, Global Quality Compliance and PMS, the Staff Quality Engineer, Quality Compliance will devise and lead the execution of actions to improve compliance, effectiveness, and efficiencies within the Quality Compliance and PMS function. Day‑to‑Day 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. 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 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. Qualifications Bachelor’s degree in engineering, science, or another technical discipline. 8 years of progressive experience in the 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. Preferred Qualifications Master’s degree in engineering, science, or another technical discipline. Prior supervisory or managerial experience. Benefits Comprehensive benefits package including full medical coverage, wellness programs, on‑site gym, 401(k) with employer match, short‑term and long‑term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and additional employee perks. Equal Employment Opportunity PROCEPT BioRobotics is an equal opportunity employer committed to diversity and inclusion. Discrimination or harassment on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or other protected status is prohibited. Pay Range Transparency Base salary $144,000–169,000 per year. Total compensation may include eligibility for an annual bonus, equity/RSUs and the benefits outlined above. Work Environment Employees will receive training and maintain trained status for all relevant aspects of the PROCEPT BioRobotics Quality Management System and adhere to associated policies. Applicant Privacy Notice When you submit an application on this site, PROCEPT BioRobotics collects personal information you provide (name, email address, phone number, résumé or CV, LinkedIn profile, optional demographics). This information is used to review your application and assess your suitability for the role. For details on privacy practices, please see the Company Privacy Policy. #J-18808-Ljbffr PROCEPT BioRobotics