Quality Assurance Specialist- Medical Devices

Wake Forest, NC 27587

Posted: 05/03/2019 Employment Type: Contract to Hire Industry: Medical Manufacturing Job Number: NCROB-201 Branch: Raleigh, NC Division: Commercial


Looking for an position that is not strenuous, provides an excellent work environment and has a fantastic company culture?

Our client is looking for an experienced quality control specialist that has experience in medical devices assembly and production.  This person has a strong attention to detail, organized, communicates well as teacher, and can show others how to perform repetitive tasks quickly and accurately assembling medical devices.


  • $10.75- $12.50/ hr. to start based on experience.   Availability for both shifts
  • 2nd shift schedule:   5:30pm- midnight. 
  • 1st shift schedule:  6:00am- 4:30pm


Benefits of working here:

  • Climate Controlled Environment
  • Opportunity to be hired directly
  • Excellent work culture and growing company with room for advancement
  • HealthCare benefits offered


General Summary

The QA Specialist’s primary responsibility is to perform product inspection and to review device history records along with providing support and training to manufacturing personnel.  The QA Specialist will be required to provide guidance and oversight to manufacturing in the management, root cause analysis, corrective action and rework of nonconforming materials.  Other duties will include performing internal audits and providing support to calibration program, assisting with environmental testing, assisting with receiving inspection.


Primary Duties and Responsibilities

  • Perform receiving inspection, in-process and/or final inspection of disposable medical devices, as well as electro-mechanical assemblies
  • Perform activities related to the documentation, control, disposition and root cause analysis of the non-conforming material
  • Provide guidance and oversight of manufacturing in the execution of rework activities
  • Write nonconforming material reports, rework instructions
  • Train manufacturing employees
  • Provide support to the QA Manager in the maintenance of the calibration program
  • Provide support to the QA Manager in the collection and maintenance of bioburden samples and data
  • Provide support to Quality Engineers in the testing and data collection during execution of validation activities
  • Perform inspections for proper machine set up
  • Conduct internal audits
  • Other Duties as assigned by the QA Manager

Environment & Working Conditions

  • Lifting -  20 lbs
  • Standing for long periods of time
  • Bending
  • Sitting for long periods of time
  • Use of rulers, calipers/micrometers, height gage, tensile and compression testing equipment, pressure decay tester, burst tester,
  • Visual -  constant visual attention
  • Primary work environment in clean rooms where gowns and hair covers are required.
  • Work well with others
  • Reliable transportation
  • Clean background


Required Qualifications

  • High school graduate
  • Strong attention to detail
  • Strong technical aptitude
  • Ability to read and understand mechanical drawings/ blueprints
  • Ability to understand ANSI Z1.4 sampling plans
  • Strong math skills                                                                                                          
  • Experience with various measuring equipment (i.e. ruler, caliper, micrometer, visual measuring equipment
  • Proficiency in development and maintenance of Microsoft Word documents and Excel spreadsheets
  • Excellent written communication
  • Excellent verbal communication skills
  • Strong leadership skills
  • Clean Background

 To Apply:  Contact us at (919) 364-4400 M-F 8am-5pm or go to www.atwork.com/raleigh

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