Senior Quality Control Inspector / PC-DMIS Programmer

 

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. Develop, qualify and maintain inspection documentation. Perform inspections and testing as required. Collaborate with Quality, Engineering and Manufacturing addressing product nonconformity issues.

Position Description and Responsibilities:

  • Develop and qualify receiving inspection measurement routines and test methods
  • Review drawing specifications to ensure objective component specification definitions
  • Develop and take ownership for quality control and operating procedures and work instructions.
  • Perform and document incoming inspections and first article inspections of purchased parts
  • Perform receipt transactions, inspections, tests, and reviews vendor documentation related to receiving of inventoried material
  • Perform receiving, in process and final inspection of returned goods as required
  • Maintain inspection documentation as required, from receiving to final testing
  • Initiate Nonconforming Materials Reports when required.
  • Provide metrology training and support to Quality, Engineering and Manufacturing
  • Perform other duties as assigned by Manager

Position Qualifications:

  • Experience with CMM PC-DMIS and OGP Smartscope Flash Software and/or Keyence Image Dimension Measuring System.
  • 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. calipers, micrometers, various gauges, 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 ten (10) 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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