Staff Quality Compliance Engineer

PROCEPT BioRobotics•San Jose, CA

1d•$144,000 - $169,000

About The Position

Reporting 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.

Requirements

Bachelorâs 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.

Nice To Haves

Masterâs degree in engineering, science, or another technical discipline.
Prior supervisory or managerial experience.

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.