This position performs various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Supplier Quality Assurance/Document Control.
• Performs gap assessments pertaining to purchased materials specification.
• Creates/revises current product specifications via Change Control / Project Plans.
• Creates/reviews Protocols, Process and Product Validations as required.
• Creates and reviews Test Methods and addresses Test Method Validation
• Creates and reviews documents required for Design History File
• Creates and reviews Risk Assessments such as FMEA, FMECA or FTA
• Supports root cause investigations and other steps of the CAPA process
• Understands basic applied GD&T concepts, metrology, typical supplier management processes, Engineering Drawing conventions/configuration types, etc.
EDUCATION and/or EXPERIENCE
• BS in Engineering, Engineering Technology, Science a minimum
• American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred
• Minimum 3 years of experience with FDA regulated industry, preferably managing supplier relationships/specification management.