Job Listing

Job Responsibilities and Tasks

• Demonstrates working understanding of medical design controls and regulatory requirements
• Develops procedures and performs incoming, in-process, final inspection, and release activities
• Interprets engineering drawings and determines methods for gauging (first article dimensions and incoming inspection dimensions); performs first article inspection and other inspection requirements
• Initiates release of material to manufacturing
• Maintain calibration system and calibrates equipment
• Maintain preventative maintenance on equipment, fixtures, and gauges
• Maintain GMP files
• Maintain training files
• Gather quality information for reports and create reports
• Support Management Reviews
• Support internal audits
• Support other quality system requirements
• Enters data into the computer for analysis
• Runs lab testing, as required
• Perform other related duties, as assigned

Requirements

• Minimum of 8 years hands-on inspection experience, preferable in a medical device area or equivalent
• Experienced in quality systems (ISO9000 and/or FDA's QSR)
• Experience with system documentation
• Demonstrate proficiency in Excel or other spreadsheets, Word
• Basic understanding of statistics
• Specialized statistical software knowledge preferred
• Demonstrated precise and thorough skill in mathematics
• CMI, CQT (ratings), preferred