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QA, Complaint Handling Technician - Test and Failure Analysis

Company: PROCEPT BioRobotics
Location: Redwood City
Posted on: January 7, 2022

Job Description:

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.


This is a temporary position of about six to nine months duration with the Quality Assurance group. As a member of the test and failure analysis team, the complaint handling technician is responsible for maintaining documentation and testing of returned products associated with customer complaints to ensure product quality. The complaint handling technician is also responsible to manage the Return Good Authorization (RGA) process to assure prompt disposition and analysis of our products.

CORE RESPONSIBILITIES (Other Duties May Be Required As Assigned)

  • Maintain documentation related to the failure analysis investigation process
  • Open compliant records are needed
  • Perform review of appropriate quality records such as Device History Records (DHR), Non-Conforming Products Reports (NCMR), etc.
  • Perform specific product testing/failure analysis of customer returned products
  • Communicate with internal resources to identify/address findings from the failure analysis process
  • Participate in identification and correction of root causes found during the failure analysis process
  • Prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends
  • 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 and 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.
    • 3+ years of industry experience
    • Ability to interpret CAD drawings
    • Experience in the use of measurement instruments
    • Ability to work with minimal supervision
    • Experience managing and performing equipment calibration
    • Ability to read and comprehend simple instructions, short correspondence, and memos
    • Ability to write simple correspondence
    • Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization
    • 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

      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 within the facility.
      • Although not an essential duty of the position, the employee may occasionally lift and/or move up to 15 pounds.

        While performing the duties of this job, the employee is regularly working in an office environment/ lab.
        • The employee and is frequently required to work in the warehouse.
        • The employee will then occasionally be exposed to a clean room and its environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn.

Keywords: PROCEPT BioRobotics, Redwood City , QA, Complaint Handling Technician - Test and Failure Analysis, Professions , Redwood City, California

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