Senior Manager, QA Sustaining, Disposable & Accessories

PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company’s AquaBeam® Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience. 
SUMMARY
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, improve processes, and inspire others to achieve challenging goals and objectives? 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.

CORE RESPONSIBILITIES

• Oversee the Quality Engineering team by developing and implementing in-depth strategies and project plans to improve product quality. 
• Create, apply, and monitor performance metrics for personnel, products, and processes.
• Identify and implement appropriate Key Performance Indicators, KPIs to monitor and improve process and product performance.
• Closely collaborate with Manufacturing Engineering team to improve production processes. 
• Implement a robust process validation, including improvement to Installation Qualification (IQ), Operational Qualification (OQ) and Process Qualification (PQ)
• Leads improvement in the collection and analysis of data.
• Leads improvements to the statistical process control (SPC) process by implementing process throughout the manufacturing and inspection processes. 
• Leads continuous improvement projects to improve product quality and reliability and to reduce cost of goods sold.
• Leads updates to (PFMEA) for all current and future devices.  
• Identify and implement projects that include, but are not limited to, reliability improvements, product manufacturability and cost reductions.
• Lead in-depth product and process failure investigations to determine root causes of failures and to implement effective and preventive actions.
• Manage the tactical and operational execution of short and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.
• Work with cross functional teams on issues of diverse scope, where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
• Interact with production management to help determine production capacities, define workspace requirements, workflow, and layout of equipment for optimal efficiency.
• Plan annual budget to ensure resources are adequate to execute approved projects and goals.
• Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce.
• Drive projects through cross functional collaboration, timeline, and schedule management.
• Prepare and issue timely status updates on active projects for review by Senior Management.
• Assure compliance to all company policies, standard operating procedures and recognized domestic/international standards.
• 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.

QUALIFICATIONS (Education, Experience, Certifications)

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
• BS in Mechanical Engineering or Qua