Quality Control Technician
Company: PROCEPT BioRobotics Corporation
Location: Redwood City
Posted on: June 13, 2022
Job DescriptionPROCEPT 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. SUMMARYThe 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
- Audit product Device History Records (DHR) to release final
product for shipment to sterilizers.
- Manages communication with sterilization supplier and audits
- Identify, record, and trend product or documentation quality
- 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
- 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
- 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
policyQUALIFICATIONS (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
- 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
- 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
DEMANDSThe 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
- The employee may occasionally lift and/or move up to up to 15
pounds. WORK ENVIRONMENT
- 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.Powered by JazzHRvj20FzZiSn
Keywords: PROCEPT BioRobotics Corporation, Redwood City , Quality Control Technician, Professions , Redwood City, California
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