· 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 DHR review and “Release to Branch Plant” function including document verification and recording incoming inspection inventory.
POSITION DUTIES & RESPONSIBILITIES:
· Inspects incoming, in process and finished products and material for visual, mechanical, and dimensional characteristics, using inspection sheets and applicable sampling plans.
· Prepares necessary 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.
· Works from inspection documentation, specifications, blue prints, written and verbal instruction.
· Performs “Roving Auditor” function involving inspection of product in a Manufacturing Flow Cell.
· Performs other related duties as required.
DHR Review Function:
· 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.
· Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
· Demonstrates strong initiative
· Exhibits positive attitude
· Cooperative attitude and inspires teamwork
· Leads by example
· Requests feedback and utilizes it to improve
· Drives cultural change
EDUCATION AND EXPERIENCE REQUIREMENTS:
· High school diploma or equivalent.
· ASQ (American Society for Quality) courses desirable.
· Zero to one year experience utilizing inspection techniques in Medical device or Pharmaceutical Industry.
· Experience with MRP/ERP systems, preferred.
· 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 communicate and work with various functional groups in a team environment.
· Ability to learn PC applications required.
· Lifting weight up to 20 pounds on regular basis and up to 50 pounds on occasional basis.
· Must be able to stand for scheduled work hours, if necessary.
· High level of concentration and attention to detail required ensuring products are properly labeled and packaged according to internal quality requirements.
· Vision in both eyes must be at least 20/30 or correctable to 20/30.
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