Do you want to be part of an innovative, cutting-edge technology, robotics company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you a leader who wants to make a difference and improve processes? Are you detailed-oriented?

At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Quality Engineering team.

This position has a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA’s Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.

• Leads Incoming Quality Control, and nonconforming materials processes.
• Single Point of Accountability for incoming inspection activities. Manage QC Supervisors and other quality inspection staff when needed.
• Own the NCMR process and manage recurring meetings with cross functional teams to ensure timely closure of investigations, root causes.
• Co-develop new in-process quality inspections and co-manage legacy ones with Mfg. Operations and Engineering.
• Ability to strategically redirect Direct Labor workforce based on production demand.
• Strong hands-on knowledge of ERP systems for data query and mining
• Excellent MS Excel skills (pivoting, formula filtering of large data set)
• Strong working knowledge of applied Statistics
• Excellent verbal, written, communication and presentation skills.
• Ability to lead cross functional discussion and “get the job done” attitude in a fast-paced environment.
• Ensures receiving inspections are established and maintained in accordance with internal procedures as well as external regulation.
• Establish and ensure timely completion of department goals and objectives.
• Develop and implement process and procedures to meet company growth and scalability.
• Experienced in developing and implementing strategies to automate incoming and in-process inspections.
• Work with cross functional groups to resolve quality issues associated with purchased parts including initial supplier contact, containment, and permanent corrective action cycle.
• Resolve technical challenges by using of advanced problem-solving skills (DMAIC)
• Support Engineering, Quality, Operations, Supplier Quality Engineering Groups with problem solving, and reject/defect investigations associated with purchased parts and oversee (NCMR) process.
• Work related travel (Domestic and overseas) 10 – 25%
• Working knowledge of Quality System within the requirements of FDA’s Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR.
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
• Understand and adhere to the PROCEPT BioRobotics Quality & EHS Policies.

• Minimum bachelor’s degree, Engineering (STEM, Biomedical, Mechanical, Electrical Engineering or similar)
• Mechanical Design experience of complex components/assemblies a huge plus.
• 5+ years of hands-on progressive technical experience in Engineering, Manufacturing or Quality in a medical device manufacturing environment required (Class II or above Medical Device, industries in complex electro- mechanical devices such as disk drives/storage or heavily regulated electro-mechanical industries like Aerospace, Automobile).
• 5+ years of experience in management and managing quality control personnel preferred.
• Minimum 3 years of experience defending regulatory audits in the front room.
• Excellent working knowledge of Geometric Dimensioning and Tolerancing (GD&T),
• Extensive working knowledge of xFMEA, Control Plan, Statistical Process Control (SPC), Containment Plans, CAPA, Measurement Fixture Development, Gage R&R, Test Method Validation
• Working knowledge of quality improvement tools and techniques
• Ability to read the room and adjust communication style in large audience meetings.
• ASQ CQE certification a plus.
• Working knowledge of process validation a plus.