Description

• Identify and review Part Qualification documents such as First Article Inspection, Gage R&R, Process Failure Mode Effect Analysis, capability study, control plan, process validation etc.
• Develop requirements for quality inspection of incoming material from supplier.
• Conduct supplier audits and manage audit corrections.
• Facilitate the completion of Supplier Corrective Action Request and Vendor Quality Notices from supplier.  Perform activities to build Design History File and Device Master Record documents.
• Perform gap analysis to update procedures and documentation to meet the new European Medical Device Regulation.
• Conduct DFx reviews with external suppliers.
• Perform manufacturing line 5S reviews.
• Participate in Root cause investigations. Identify and Mitigate Quality Risk inside plant.
• Participate in engineering design reviews and provide inputs.
• Review and disposition product design and manufacturing process changes orders.
• Perform manufacturing area audit to review compliance to FDA 21 CFR Part 820 regulation.
• And any additional duties as deemed necessary for the project.