Quality Control Inspector II
About The Position
The Quality Control Inspector II is responsible for ensuring the inspection and release of incoming raw materials, finished products, and final inspection of assemblies and post-sterile product. This role also ensures the calibration of all tools used in manufacturing or for quality decisions. The inspector will follow all safety guidelines, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP). They will maintain accurate inventory records, manage the quarantine area for non-conforming materials, and ensure the segregation of sterile and non-sterile products. Additionally, the inspector will maintain organized and accurate paper files, prioritize inspections based on supervisor instructions and manufacturing demands, and initiate Non-Conformance Material Reports (NCMRs) for any non-conforming product or events. This position supports the Quality Management team in quality reviews and audits, ensures timely calibration of equipment, and performs other duties as assigned by the supervisor, all while maintaining compliance with Quality System procedures and company policies.
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
- Knowledge of fundamental Metrology practices and principles
- Superb attention to detail
- Good oral and written communication skills
- Ability to read and understand drawings
- Ability to follow directions
- Visual acuity to distinguish colors and recognize non-conforming parts
- 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
Nice To Haves
- Associate degree preferred
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
