· Associate degree, with 5+ years of quality related experience or equivalent, medical device industry experience.
· Knowledge of FDA 21 QSR 820 current ISO standards 13485 (medical device Protocol) domestic and international.
· Familiarity with SAP or equivalent Enterprise Resource Planning systems (ERP).
· Knowledge and experience with Geometric Dimensioning and Tolerance (GD&T).
· Experience in mechanical inspection techniques involving Weldments and large machined components.
· Performs visual, dimensional, mechanical, and optical inspections per instructions.
· Uses basic to complex inspection measurement equipment including microscopes, optical comparator and coordinate measurement equipment to set up and verify dimensions and geometric tolerances for compliance.
· Works from engineering drawings, internal and external specifications, quality assurance standards, test procedures, and verbal instructions to determine acceptance of product
· Experience with CMM and other multi-mode measurement systems.
· Basic computer, Word and Excel skills in order to create and update inspection documents and metrics.
· Uses computer to document quality records, first article and dimensional reports, and job status, including the scanning and filing of records
· Ability to prioritize and multi-task in a flexible, fast paced and challenging environment.
· Is detail-oriented and has the ability to work proactively and effectively with minimal supervision.
· Must be team-oriented, possess a positive attitude and work well with others across functional groups, co-workers, and suppliers.
· Excellent time management and follow-up skills.
· Requires strong and effective verbal, written, and interpersonal communication skills.