Senior Quality Control Inspector / PC-DMIS Programmer
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
- 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
Certificates Licenses and Registrations
- ASQ CQI (Certified Quality Inspector) preferred
- 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