Quality Control Inspector II

Essential Duties and Responsibilities:

Responsible for ensuring the inspection and release of incoming raw materials, finished products, and final inspection of assemblies and post sterile product. Also, ensures the calibration of all tools used to manufacture or make quality decisions.

• Inspect incoming raw materials, reviewing for accuracy of shipment, documentation and the acceptability of parts
• Complete Finished Goods, Device History Review
• Follows all safety guidelines.
• Follows Good Manufacturing Practices and Good Documentation Practices
• Record all transactions to ensure accuracy of inventory.
• Maintain the quarantine area to ensure that all non-conforming, rejected material and material waiting for inspection are clearly labeled with status.
• Maintain segregation of sterile and non-sterile product.
• Maintain, organize and ensure paper files are accurate and complete.
• Prioritize inspection based on supervisor instructions and demands of manufacturing and product development.
• Initiate nonconformances (NCMRs) for nonconforming product/events.
• Support Quality Management in performance of quality reviews and audits.
• Ensure that items that require calibration are sent out for calibration in a timely fashion and that records and documentation are completed per the SOP.
• Perform related duties as assigned by supervisor
• Maintain compliance with Quality System procedures and company policies

Education and/or Work Experience Requirements:

• Experience using a vision system, micrometers, calipers and other tools and gauges to perform inspection to verify dimensional accuracy according to prints, parts manuals, company standards, and other specifications
• Must have a knowledge of fundamental Metrology practices and principles
• Superb attention to detail
• Must have good oral and written communication skills
• Ability to read and understand drawings
• Ability to follow directions
• Must have visual acuity to distinguish colors and recognize non-conforming parts
• Must be proficient in using a Windows PC, Microsoft Office products
• Understanding of GMP and ISO quality systems
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices
• Ability to initiate Document Change Orders for Receiving Inspection Forms and Procedures
• 2 – 5 years of experience performing quality and/or visual inspections
• High school diploma or GED required
• Associate degree preferred

Physical Requirements:

• Position is primarily sedentary, and employee may be required to sit for extended periods of time.
• Standing, walking and meeting activities are required frequently throughout the workday.
• Employee must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.).
• A large portion of the day is spent communicating orally in person and by phone.
• Normal sight or corrected vision is required to read documents and use standard computer terminals.
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other
• federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
• Must be able to lift and carry up to 50 lbs
• Must be able to talk, listen and speak clearly on telephone