Client and CAPA activities - Execute Investigations, Root Cause Analysis, Correction, Corrective and Preventive Action activities in accordance with the *** North America Quality System for NCRs and CAPAs including: capturing data and investigations associated with product deviations, product nonconformances, CAPAs, scrap, and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Support Change Control activities - Originate and review internal operating procedures and specifications through the Document Change process
Adherence to regulations - Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices.
BS in a Physical Science or Engineering or Equivalent Experience. Required
Experience in Quality Assurance and/or other regulated industry or similar experience. Preferred
Strong technical writing and general problem-solving skills. Required.
Manage multiple priorities and work with interruptions. Required
Requires Vision Assessment (20/20 near visual acuity & acceptable color vision) •
Last updated on Mar 10, 2021