Senior Manager, Supplier Quality

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We 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.
The Opportunity That Awaits You:   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. Get ready to transform lives and shape the future of healthcare! 

What Your Day-To-Day Will Involve:

• Oversee the Supplier Quality team by developing and implementing in‐depth strategies and project plans to improve supplier selection, supplier qualification (including service and software related), and approvals for robotic related single use devices, consumables, accessories, and capital equipment. 
• The Senior Supplier Quality Engineering Manager will be responsible for the hiring, development, and performance management of the Supplier Quality team. 
• Create, apply, and monitor performance metrics for personnel, product, and processes.
• Identify and implement appropriate Key Performance Indicators, KPIs to monitor supplier product quality and improve supplier performance.
• Closely collaborate with Supply Chain, receiving inspection, Supplier Engineering, R&D team to drive supplier selection, assess supplier risk, qualification, and validation processes. 
• Drive the supplier review board, to report on supplier performance and quality events
• Ensure supplier audits are performed periodically and communicate issues in a timely manner.
• Collaborate cross functionally to Identify and implement projects that include, but are not limited to, reliability improvements, process efficiency, product manufacturability and cost reductions.
• Co‐lead with Supplier Engineering and R&D in‐depth product and process failure investigations via NCMRS/CAPAs/SCARs to determine root causes of failures and to implement effective and preventive actions.
• 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 supply chain and production management to help determine supplier 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.
• Oversee the product environment compliance strategy, process and deploy applicable standard operating procedures for new product development and design changes to existing products.
• Provide oversight to PROCEPT compliance to EU requirements of CE, IEC, supply chain act and FDA regulations of medical devices with respect to the Environmental Regulations of WEEE and Battery, REACH, Conflict minerals, China RoHS and EU RoHS.
• Monitor progress of supplier related activities and internal processes to close gaps and incorporate compliance into new product design while maintaining compliance for existing products.
• Communicate product compliance status to s