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Quality Assurance Engineer

2 months ago

San Jose, California, United States PROCEPT BioRobotics Full time
About the Role

We are seeking a highly skilled Quality Assurance Engineer to join our Capital Operations team at PROCEPT BioRobotics. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality and reliability of our medical devices.

Key Responsibilities
  • Represent Quality in Capital Equipment Production and Service Operations
  • Establish and maintain master validation programs, including site and individual products and process master validations activities
  • Work closely with manufacturing engineers to review and modify manufacturing process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality requirements
  • Support manufacturing engineers on continuous product and process improvement through detailed failure analysis for nonconformances
  • Support or implement manufacturing test equipment to identify failure causes/symptoms
  • Participate in supplier material related issues, including coordination of Material Review Board (MRB) activities to ensure the timely assessment of potential non-conforming products
  • Support requirements for in-process inspections, and lot release testing, including statistical sampling strategy and test methods
  • Implement effective and compliant solutions for manufacturing quality process corrections, retrospective and remediation action plans, and for corrective and preventive actions
  • Assist with the development and maintenance of product process Failure Mode and Effects Analysis (FMEA) activities and maintenance of product risk management files
  • Establish and maintain process controls/Statistical Process Control (SPC) for specific production processes
  • Ensure compliance of the capital production personnel to the training program
  • Collaborate with Supplier Engineering on supplier issues
  • Audit and maintain Device Master Record
  • Drive, review, and disposition of Returned Goods Authorization (RGA)
  • Support complaint handling as required
  • 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 Environmental Health and Safety (EHS) policies
Requirements
  • Bachelor's degree
  • 2+ years related experience and/or training, or equivalent combination of education and experience
  • A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971
  • Familiarity with test methods, process verification, and capital production
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
  • Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
  • Must have a working knowledge of statistics
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Preferred Qualifications
  • BS Engineering (STEM, Biomedical, Mechanical, Electrical Engineering or similar) from a four-year college or university
  • Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military or nuclear
  • EU Medical Device Directive is a plus