• Support document control, such as taking ownership of change order/change activity for coworker Maintain Device History Record (DHR)/Lot History Record (LHR) log – creation of new lot numbers upon request and subsequent updates as appropriate.
• Perform final review of manufacturing DHR/LHR at close of or during manufacturing process and product release.
• Perform review of DHR/LHR for accuracy, GDP, and correct parts, and creation of release label.
• Perform final label and packaging inspection and release.
• Compile, review for accuracy, and archive completed and approved DHR/LHR
• Compile and archive completed and approved incoming inspection records
• Support incoming inspection as needed – understand and utilize the capability of measuring tools/fixtures; understand material
  specifications/inspection requirement of the components and parts; properly document inspection outcome

• High school diploma or equivalent qualification.
• 1+ years’ experience working in manufacturing, or related field.
• Excellent knowledge of Office and Excel.
• Good math and technical skills.
• Working knowledge of quality control standards, and when necessary, testing techniques as well.
• Working knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.

• 1+ years prior medical device experience preferred.

Pay Range: $24/hr - $28/hr.