Quality Control Technician II

3 weeks ago


San Jose, California, United States PROCEPT BioRobotics Full time
Join Our Team as a Quality Control Technician II

At PROCEPT BioRobotics, we are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics. As a Quality Control Technician II, you will play a critical role in ensuring the quality and safety of our products.

Key Responsibilities:
  • Represent Quality in Capital Equipment Production and Service Operations
  • Assist in and/or perform final review of manufacturing Device History Records
  • Perform labelling and packaging inspection for CE, Warehouse, and Service Production
  • Compile and archive completed and approved Device History Records
  • 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
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
Preferred Qualifications:
  • Process and Labelling inspection experience
  • Understand GMP and GDP

We offer a comprehensive benefits package, including full medical coverage, wellness programs, on-site gym, 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws.

Procept is committed to fair and equitable compensation practices. The pay range for this role is $31 an hour - $38 an hour, plus eligibility for an annual bonus and equity/RSUs.



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