Full-Time

Quality Control Technician II

Capital Equipment

Posted on 9/13/2024

PROCEPT BioRobotics

PROCEPT BioRobotics

501-1,000 employees

Develops robotic solutions for BPH treatment

Robotics & Automation
Healthcare

Compensation Overview

$31 - $38Hourly

+ Bonus + Equity/RSUs

Junior, Mid

San Jose, CA, USA

Position requires onsite presence in San Jose, CA.

Category
Diagnostics & Laboratory Professionals
Medical, Clinical & Veterinary
Requirements
  • High School Diploma or equivalent, technical training, or equivalent experience.
  • 2- 4 years of related experience in the Medical Device Industry or other highly regulated industry
  • Experience performing DHR audits
  • Knowledge of Quality Systems, FDA regulations, ISO 13485, and applicable regulatory requirements
  • Ability to work within a team and as an individual contributor in fast-paced environment
  • Ability to work with minimal supervision
  • Strong organizational and follow up skills as well as high attention to detail
  • Solid understanding of MS Office applications
Responsibilities
  • Represent Quality in Capital Equipment Production and Service Operations
  • Assist in and/or perform final review of manufacturing DHR (Device History Records)
  • Perform labelling and packaging inspection for CE, Warehouse, and Service Production
  • Compile and archive completed and approved DHR
  • Compile and archive completed and approved incoming inspections records as required.
  • Identify, record, and trend product or documentation quality issues as required
  • Perform transactions in the ERP system to quarantine or release product and finished goods inventory.
  • Issue nonconformance reports as necessary and work with Quality, Operations, Manufacturing, and R&D on resolution.
  • Assist on nonconformance material movement and ERP transaction as required.
  • Work may involve processing Product Return or RGA (Returned Goods) transactions
  • Assist on equipment labeling related to preventative maintenance and calibration
  • Audits inspection processes, equipment, and provides feedback for continuous improvement.
  • Assists with engineering studies and measurement systems analysis as required.
  • Assists with In-process inspections as required.
  • Takes part in cross-functional and functional projects related to Product Release
  • 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 Quality and EHS Policies

PROCEPT BioRobotics develops robotic solutions specifically for treating benign prostatic hyperplasia (BPH), a condition that affects many older men by causing prostate enlargement and urinary issues. Their main product, the AquaBeam Robotic System, utilizes Aquablation therapy, which combines real-time imaging, robotics, and waterjet technology to precisely remove prostate tissue in a minimally invasive manner. This system is designed for urologists and healthcare facilities, focusing on enhancing patient outcomes and making surgical procedures more efficient. Unlike competitors, PROCEPT BioRobotics emphasizes predictable results and reduced complications, which has led to their technology being recognized in clinical guidelines. The company's goal is to improve the quality of life for patients suffering from BPH through advanced surgical solutions.

Company Stage

IPO

Total Funding

$319.1M

Headquarters

Redwood City, California

Founded

2009

Growth & Insights
Headcount

6 month growth

0%

1 year growth

1%

2 year growth

2%
Simplify Jobs

Simplify's Take

What believers are saying

  • Increasing adoption of robotic-assisted surgeries boosts demand for AquaBeam System.
  • Global urology devices market projected to grow at 6.9% CAGR until 2030.
  • FDA's supportive regulatory environment favors innovative medical technologies like PROCEPT's.

What critics are saying

  • Competition from Intuitive Surgical and Medtronic may impact market share.
  • $175 million public stock offering could lead to shareholder dilution.
  • Reliance on AquaBeam System makes company vulnerable to technological failures.

What makes PROCEPT BioRobotics unique

  • AquaBeam Robotic System offers image-guided, minimally invasive urologic surgery.
  • Aquablation therapy provides effective outcomes regardless of prostate size or surgeon experience.
  • PROCEPT has over 100 peer-reviewed publications supporting Aquablation therapy's benefits.

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Benefits

Health Insurance

401(k) Company Match

401(k) Retirement Plan

Paid Vacation

Paid Parental Leave

Paid Holidays

Wellness Program

Gym Membership

INACTIVE