Quality Control Inspector

 

Company Overview:

Intuity Medical is a privately-held, fast paced, growing medical device company located in Fremont, CA that is developing a greatly simplified glucose monitoring system for people with diabetes.  The Company's proprietary technology re-invents the glucose testing procedure making it easier and more convenient to use.  

Summary of Primary Responsibilities:

Perform wide range of inspection of incoming purchased parts, raw material, assemblies, subassemblies, pre-processed and post-processed parts, returned goods. Collaborate with Quality, Engineering and Manufacturing addressing product nonconformity issues.

Position Description and Responsibilities:

  • Perform incoming inspections of purchased parts
  • Perform receipt transactions, inspections, tests, and reviews vendor documentation related to receiving of inventoried material
  • Perform and document detailed formal inspection records
  • Perform and document first article inspections as required
  • Perform receiving, in process and final inspection of returned goods as required
  • Provide input for inspection methods and improvements related to the job
  • Maintain inspection documentation as required, from receiving to final testing and coordinating filing with the Quality Lead
  • Initiate Nonconforming Materials Reports when required
  • Perform other duties as assigned by Manager

Position Qualifications:

  • Ability to interpret engineering drawings (GD&T), receipt/shop travelers, purchase orders, procedure, bills of materials and supplier documentation
  • Ability to utilize various inspection tools (i.e., optical comparator or other vision inspection systems, micrometers, various gages, etc.)
  • Ability to manage workload to effectively and efficiently complete tasks within time constraints
  • Act as a team member to define and resolves issues
  • Familiar with ISO13485 and FDA QSR regulations
  • Knowledge of ANZI Z1.4 standard on Sampling Plans as it relates to verification activities
  • Competent computer and software application skills
  • Possess a strong work ethic, a positive attitude, and is detail oriented
  • Excellent verbal and written communication skills

Desirable Skills:

Certificates Licenses and Registrations

  • ASQ CQI (Certified Quality Inspector) preferred

Minimum Education/Experience:

  • AS or AA degree preferred.  Experience will be considered
  • Minimum five years of QA inspection experience in the medical industry or related manufacturing industry or an equivalent combination of education or experience

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