Quality Inspector, Medical Device, Contract or Permanent

Franklin Lakes, New Jersey | Quality Assurance / Safety

Quality Control Inspector – Medical Device, Contract or Permanent Full Time

 

These opportunities come along rarely and when they do, they demand your attention.  Our client is a med device start-up involved in a novel technology that addresses an unmet clinical need and it is a group of people who have successfully introduced other new product concepts to the market with several start-ups. 

 

Your core skills in hands-on Inspection and the tools used to inspect plastic components as well as metal-based tooling are very important.  You must have experience in the use of a Comparator in combination with overlays to confirm part shape accuracy as well as with other, commonly used inspection tools; e.g. micrometer, calipers, gage blocks, dial indicators, etc. 

 

We need you to walk in the door, ready to take on the responsibility of confirming incoming materials results and accurately communicate those data internally.  Our client is in the midst of a NP release and this role is critically important to them; as regards its future they have plans in place for several other releases so this need is ongoing. 

There will be cross-functional interaction within Quality, as well as with R&D, Operations and Management so your ability to express metrology to others will be a key component of your success.  Your documentation will have to be compliant to ISO 13485 and FDA 21 CFR 820 and your familiarity with Risk Analysis will be welcomed.   Still interested?  Read on. 

 

RESPONSIBILITIES

  • Demonstrable experience in the use and application of Comparators and Overlays
  • Experience in the requirements of a regulated inspection process
  • Familiar with the use of micrometers and other inspection tools as listed above
  • Accurately records data, both visual and measurable

REQUIREMENTS: 

  1. AS/AAS and 2+ years of hands-on inspection experience or a BS in an engineering discipline with 1-2 years’ experience
  2. Experienced in blueprint reading with an understanding of GD&T
  3. Familiar with the demands of accurate data recording as required by ISO or other Quality Systems
  4. Experience working with outside vendors a plus
  5. Quality Systems experience in ISO, AS, or TS highly desirable
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