Our client, a medical device contract manufacturing company, has an immediate opening for a Quality Control Inspector. This role will work with other personnel to provide various inspection services within the bounds of the company's quality management system, following defined AQL inspection sampling plans.

Responsibilities:

• Perform incoming material inspection following work instructions and component quality
  inspection plans
• Follow specific AQLs where identified
• Perform in-process inspection on subassemblies and finished devices as required
• Utilize a variety of inspection tools including but not limited to visual inspection, digital height gauges, calipers, optical comparators, vision systems, durometers, and more
• Work with operators and supervisors on quality policies and procedures; assist in training of employees on new policies and procedures
• Determine acceptability of rework by conducting inspections and physical tests of reworked product
• Document finished product status by recording and summarizing raw materials, in process, and finished product inspection and physical test data, updating quality assurance
  databases as required
• Maintain quality assurance operations by following quality assurance policies and
  procedures, reporting needed changes
• Perform sampling and testing of components, materials, and equipment
• Ensure that raw materials and products meet company standards
• Other responsibilities as required

Requirements:

• 4+ years in medical device quality assurance or related field
• A working understanding of ISO 13485 and FDA Quality System regulations
• Understanding of inspection practices and AQL sampling
• ERP experience is beneficial
• Use of inspection tools required
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and
  written) in English
• Ability to work with minimal supervision autonomously and in a team environment
• Take responsibility for task and time management
• Ability to learn new tasks quickly
• Attention to detail to understand and meet the requirements
• Ability to access, open, and save files to a computer
• Ability to work with others collaboratively