Senior Manager, Supplier Quality

Company Overview

Embark 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!

• 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 senior management and internal stakeholders.
• Travel – up to 30%.  Travel will include domestic and international destinations and may be for over a week at a time.
• 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

• Bachelor’s degree in STEM or Quality related education or an engineering discipline required, Master’s degree preferred.
• At least 12+ years of progressive experience in medical device quality engineering or supply chain.
• Experience leading technical teams and/or managerial supervisory experience preferred.
• Must be familiar with 21CFR 820, ISO13485, EU‐MDR requirements for manufacturers and maintain the production operations in compliance with these requirements.
• ASQ CQE, CQA, Black Belt Six Sigma certification a plus
• Demonstrated reasoning ability to apply principles of logical or scientific and critical thinking
• Demonstrated ability to be a proactive and collaborative leader in a dynamic operations and engineering environment.  This individual possesses a bias toward action and results (no stones left unturned).
• Able to multi‐task, establish clear expectations, set objectives and deliver results within tight deadlines.
• Excellent interpersonal and communication skills across all levels of the organization.
• Must be able to work in a dynamic, fast‐paced environment with strong ability to establish technical and professional credibility and demonstrate MUST‐DO attitude.
• Must be able to manage and resolve conflicting product and project requirements and be a strong team player with ability to collaborate across functional areas. 
• Expected to present supplier quality related topics in the front room for regulatory audits (FDA, MDSAP, MDR)

Understanding PROCEPT's Culture

At 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!

BENEFITS OF WORKING AT PROCEPT! 

PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.

PAY RANGE TRANSPARENCY

Procept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.

WORK ENVIRONMENT

We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.