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 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.

CORE RESPONSIBILITIES (Other duties may be required as assigned)

• Create and maintain supplier files for all providers of components, subassemblies, and services to PROCEPT-BioRobotics.
• Create and maintain supplier score cards for all required supplier
• Create, maintain, and execute supplier audit program
• Responsible for supplier qualification, approvals
• Responsible for maintaining approve supplier list (ASL)
• Responsible for process validation and component validation at a supplier level
• Support establishment and maintenance of supplier risk assessment
• Maintain supplier corrective and preventive action (SCAR) program
• Responsible for proving data to support Management Reviews, Supplier Review Boards, etc.
• Participate in the product development process to identify, validate, and approve suppliers
• Represent the department in external audits, such as FDA, ISO, etc.
• Support training program to communicate Quality System requirements to organization at all levels
• Review and modify product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements
• Review and provide feedback of protocols and reports, test vendor qualification, and testing management
• Assist with the development and maintenance of product risk management files
• Recommend requirements for first article inspection, incoming and in-process inspections, and lot release testing, including sampling strategy and test methods
• Participate in failure investigations to analyze internal system or process failures and to implement corrective and preventive action
• Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriate quality controls are implemented
• Identify and implement good quality engineering practices, including statistical methods and root cause analysis tools
• Participate in supplier material related processes which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products
• Support continuous product and process improvement through detailed failure analysis for non­conformances, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions
• 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 EHS Policy

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. 

• Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university
• 5 years related experience and/or training; or equivalent combination of education and experience
• Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military or nuclear
• A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO10993, ISO 11135, and the EU Medical Device Directive is a plus
• Certification for ISO 13485 auditor. Lead auditor certification a plus
• Familiarity with test methods and standards for the design, verification, and validation of medical device products is required
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedure manuals
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
• Ability to apply concepts of basic algebra and geometry
• Must have a working knowledge of statistics
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 15 pounds. 

WORK ENVIRONMENT

• While performing the duties of this job, the employee regularly works in an office environment. 
• COVID-I9 Vaccine Requirement: All PROCEPT BioRobotics employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical or religious exemptions.