Quality Control Inspector (Medical Device)

Our client, a Global Medical Device Manufacture has an immediate opening for a Quality Control Inspector for a 18 Month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

Perform quality assurance and quality control inspection duties, including inspection of implants, instruments and gauges as required to ensure the dimensional and visual integrity of product in accordance with all required quality specifications, standards, goals and objectives. Perform receiving inspection and related activities

Position Description (Principle Duties and Responsibilities)

• Perform dimensional and visual inspection to blueprint using standard gages, custom gages and comparators
• Read and inspect to blueprints and/or inspection guide sheets
• Perform Document Review and Product Verification Inspection (PVI) in compliance to GMP requirements
• Perform material and component Receiving Inspections
• Inspect, calibrate and qualify gages
• Verify First Article Inspection (FAI) data
• Perform Oracle system transactions related to Router Inspections
• Segregate, quarantine and complete documentation for non-conforming materials when necessary.

Requirements

• Must have 3+ years of product inspection experience in a cGMP manufacturing environment -Prefer experience with inspection of hand finishing, buffing, laser-marking, masking or blasting processes for implants, instruments or other production parts
• Demonstrated ability to read blueprints
• Demonstrated proficiency in the use of all standard inspection tools including calipers, micrometers, height gages and comparators
• Demonstrated understanding of Inspection Sampling Plans
• Demonstrated familiarity with GD&T
• Demonstrated computer skills including basic proficiency in MS Outlook and intermediate proficiency in MS Word and Excel
• Demonstrated understanding of FDA CFR 820 and EN 13485 Regulations
• Demonstrated experience in performing incoming receiving inspection
• Prefer demonstrated understanding of packaging or clean line process and assembly for implants, instruments, or production parts.