Quality Engineer- Capital Equipment

September 10

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PROCEPT BioRobotics

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Aquablation therapy - the BPH treatment of choice for all prostates.

Surgical Robotics

201 - 500

Description

•Represent Quality in Capital Equipment Production and Service Operations •Establish and maintain master validation program, 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 nonconformance's. •Support or implement manufacturing test equipment to identify failure causes/symptoms. •Participate in supplier material related issues which include coordination of 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 FMEA activities and maintenance of product risk management files. •Establish and maintain process controls/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 Good 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 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