Provide higher-level inspection services with minimal instruction. Distinguish issues arising from daily incoming inspection needs / reports that should be reviewed by a supervisor or engineer and able to prioritize multiple tasks. Proficient in use of measuring instruments in Quality Assurance. The inspection of inhouse and vendor purchased products, raw material and services.
The inspection of packaging and labeling materials used for medical devices.
Performs Device History Record (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.
• Assist in training of co-workers in new or improved techniques in areas of experience.
• Assists in identification and segregation of non-conforming materials/products.
• Follows inspection documentation, specifications, blue prints, written and verbal instruction.
• 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 one’s 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: scales, calipers, micrometers, dial indicators, optical comparators, plug gauges, hardness testers, etc.
• Good math skills, color verification and good hand/eye coordination.
• Ability to communicate and work with various functional groups in a team environment.
• Ability to learn PC applications required
EDUCATION & EXPERIENCE REQUIREMENTS
• High school diploma or equivalent.
Experience with SAP ERP system is a plus
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