Require a basic knowledge of mechanical systems, critical thinking skills, and proficiency with standard testing tools, calipers, depth gauge, microscope, and CMM programs.
1. Associate degree, with 5+ years of quality related experience or equivalent, medical device industry experience.
2. Knowledge of FDA 21 QSR 820 current ISO standards 13485 (medical device Protocol) domestic and international.
3. Familiarity with SAP or equivalent Enterprise Resource Planning systems (ERP).
4. Knowledge and experience with Geometric Dimensioning and Tolerance (GD&T).
5. 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.
6. Basic computer, Word and Excel skills in order to create and update inspection documents and metrics.
7. Uses computer to document quality records, first article and dimensional reports, and job status, including the scanning and filing of records
8. Ability to prioritize and multi-task in a flexible, fast paced and challenging environment.
9. Is detail-oriented and has the ability to work proactively and effectively with minimal supervision.
10. Must be team-oriented, possess a positive attitude and work well with others across functional groups, co-workers, and suppliers.
11. Excellent time management and follow-up skills.
12. Requires strong and effective verbal, written, and interpersonal communication skills.