Staff Quality Compliance Engineer

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

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.Understanding PROCEPT's CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!The Opportunity That Awaits YouReporting to the Senior Director, Global Quality Compliance and PMS, the Staff Quality Engineer, Quality Compliance will devise and lead execution of meaningful actions to improve the compliance, effectiveness, and efficiencies of processes within the Quality Compliance and PMS function. This role will represent Quality Compliance and PMS when partnering with internal department and cross-functional stakeholders and process owners. Develop and implement Quality tools to monitor key quality metrics that reflect health of the Quality System and identify opportunities for continuous improvement to scale workflows in support of evolving business needs.What Your Day-to-Day Will InvolveLead 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.The Qualifications We Need You to PossessBachelor’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.The Qualifications We Prefer You to PossessMaster’s degree in engineering, science, or another technical discipline.Prior supervisory or managerial experience.Pay Range for this role: