Job Description
Overview of Job:
You will perform critical functions in writing protocols, assisting in qualifying our Denville laboratory,
calibrate and perform preventive maintenance on our testing equipment. You will also monitor
qualifying events at our laboratory and manufacturing partner, including reviewing batch releases.
Responsibilities:
• 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
Professional Experience:
• 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
• Experience in Quality
Education:
• High School degree or above. Good Math skills are a must
Physical Demands:
• Must be able to perform light lifting of up to 20 pounds
• Stand for 4 hours
• 5% periodic traveling (e g supplier audits, projects support as needed)