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Quality Technician Swing Shift

Company: PROCEPT BioRobotics
Location: Redwood City
Posted on: June 26, 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.

Summary

The Quality Technician will serve as the liaison between the Quality, Operations, Manufacturing, and R&D teams and will be responsible for the maintenance and execution of the equipment management and product release process. Additionally, the Quality Technician will be involved in additional quality system areas such as incoming and in-process inspections, RGA process, and supporting data acquisition and communication activities.

The ideal candidate must possess high attention to detail, have strong interpersonal and communication skills, and the ability to prioritize tasks. The candidate must establish and maintain a professional working relationship with the Quality, Operations, Manufacturing, and R&D teams.

CORE RESPONSIBILITIES (Other Duties May Be Required As Assigned)

  • Audit product Device History Records (DHR) to release final product for shipment to sterilizers.
  • Manages communication with sterilization supplier and audits sterilization certificates.
  • Identify, record, and trend product or documentation quality issues.
  • Perform transactions in the ERP system to quarantine or release product to sterilization and finished goods inventory.
  • Issue nonconformance reports as necessary and work with quality engineers on resolution.
  • Communicate with internal departments to ensure timely execution of preventive maintenance and calibration activities.
  • Coordinate calibrations with external suppliers.
  • Maintain calibration system including database.
  • Maintain preventive maintenance system.
  • Track and report equipment metrics.
  • Audits inspection processes, equipment, and provides feedback for continuous improvement.
  • Assists with engineering studies and measurement systems analysis as required.
  • Assists with Incoming and In-process inspections as required.
  • May train inspectors on new processes and procedures.
  • 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.
    • High School Diploma or equivalent, technical training, or equivalent experience.
    • Minimum of 5 years of related experience in the Medical Device Industry or other highly regulated industry
    • Experience managing equipment calibrations
    • Experience performing DHR audits
    • Experience managaning calibration and preventive maintenance systems
    • Knowledge of Quality Systems, FDA regulations, ISO 13485, and applicable regulatory requirements
    • Ability to interpret CAD drawings
    • Familiarity with inspection equipment (CMM, Vision Systems, calipers, gages, etc.)
    • Ability to work within a team and as an individual contributor in fast-paced environment
    • Strong organizational and follow up skills as well as high attention to detail
    • Solid understanding of MS Office applications
      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.
      • The employee may occasionally lift and/or move up to up to 15 pounds.
        WORK ENVIRONMENT
        • Typical working hours: 3pm - 11:30pm
        • The employee may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment will be assigned and worn.
        • While performing the duties of this job, the employee is regularly working in a warehouse and clean room 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.

Keywords: PROCEPT BioRobotics, Redwood City , Quality Technician Swing Shift, Professions , Redwood City, California

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