- 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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