Descripción del Trabajo
The Quality Inspector is responsible of the inspection of in-house and vendor purchased products, raw material and services. The inspection of packaging and labeling materials used for medical devices.
Performs Device History Records (DHR) review and “Release to Branch Plant” function including document verification and recording incoming inspection inventory
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Inspects incoming, in process and finished products and material for visual, mechanical, and dimensional characteristics, using inspection sheets and applicable sampling plans.
• Prepares required documentation and ensures paperwork compliance on all inspected items.
• Assists in identification and segregation of non-conforming materials/products.
• Follows inspection documentation, specifications, blue prints, written and verbal instruction.
• Performs “Roving Inspection” function involving inspection of product in a Manufacturing Flow Cell.
• Performs device history review inspection and final release of product to inventory control/warehouse.
• Performs filing and supports the imaging and verification process for Device History
• Records and other Quality System documentation.
• Know and follow all laws and policies that apply to Inspector 1 job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Participate in compliance program-related activities as denoted by your Supervisor or Compliance Officer.
• Demonstrate and inspire the behaviors that reinforce Our Credo.
• Develop deep insights into the needs of our patients, customers, markets and communities.
• Drive innovation; anticipate and shape industry and market changes to advance health care globally.
• Create an environment where leadership and talent development is top priority.
• Deliver results by inspiring and mobilizing people and teams.
• Ability to communicate and work with various functional groups in a team environment.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
• Job is NOT directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• Ability to read and interpret measuring instruments, including but not limited to: calipers, micrometers, dial indicators, optical comparators, plug gauges, hardness testers, etc.
• Good math skills, color verification and good hand/eye coordination.
• Ability to learn PC applications required
EDUCATION & EXPERIENCE REQUIREMENTS
• High school diploma or equivalent.
• 0-1 year experience utilizing inspection techniques in Medical device Industry.