Quality Inspector

Job DescriptionJob Description

The Quality Inspector / Document Control Technician will work in a fast-paced environment using a variety of inspection techniques and equipment to confirm supplied and internal materials meet specifications. This position requires understanding and indicating inspection status, maintaining product traceability and non-conforming material control. The primary responsibilities for the position are supporting inspection with receiving, first articles, labeling, final inspection of material and medical devices.. The position also includes assisting in document control with a variety of activities. Simple statistical analysis may also be required. The ideal candidate will have excellent communication skills, be detail-orientated, and have flexibility to change needs based on project requirements

Key Responsibilities:

• Utilize experience and skills to use inspection tools including vision system, thickness gages, drop indicators, micrometers, calipers, laser micrometers, pin gages, and other testing equipment as needed
• Keep accurate records of inspections using pre-determined processes
• Identify non-conformities and communicate to necessary departments, along with participation in disposition of non-conformances
• Recommend updates to quality inspection documentation or specifications as needed
• Understand Grand Avenue Software System and assist with Document Control
• Create, review, and approve Documentation Change Requests
• Work with cross-functional teams to perform duties as needed
• Perform first-in-first out inspections and prioritize inspection based on various project needs
• Priorities Documentation Change Requests based on various project needs
• Ensure training is complete prior to performing inspections and assist with training other individuals as needed
• Perform line clearance to ensure all materials from the previous lot have been removed
• Work from instruction in a variety of documentation including manufacturing procedures, specifications, drawings, and inspection instructions
• Scan DHR documentation and file both hard copy and scanned versions to appropriate folders/files
• Work with minimal supervision
• Lift up to 20 pounds
  
  

Qualifications:

• High school diploma or equivalent
• 2+ years prior experience in medical device is required
• Proficiency with Microsoft Word and Excel
• Ability to read, write, count, and understand English
• Ability to perform tasks using various business software systems supporting inventory and document control
• Basic knowledge of medical device regulations (FDA 21CFR820, ISO 13485).

This job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be an entire list of all activities, tasks and skills required of employees in this position.