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Quality Control Supervisor at Intuity Medical
Fremont, CA, US

Summary of Primary Responsibilities:

Responsible for supervising the Quality Control function at Intuity Medical. Collaborate with Quality

and Product Development on incoming inspection of materials.

Position Description and Responsibilities:

  • Supervise QC Inspectors.
  • 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, first article inspection, and gage R&R.
  • Perform batch record review of in-process materials and finished goods
  • 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 manage workload to effectively and efficiently complete tasks within time constraints
  • 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, batch records and supplier documentation
  • Act as a team member to define and resolves issues
  • Familiar with ISO13485 and FDA QSR regulations
  • Knowledge of C=0 and ANSI/ASQ Z1.4/Z1.9 standard on Sampling Plans
  • 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:

  • BS degree in sciences, engineering or related field preferred.  Experience will be considered.
  • Minimum seven (7) years of QA experience preferably in the medical device industry or related manufacturing industry, or an equivalent combination of education and experience.  Supervisory experience preferred.

Supervision:  Supervised by Manager of Quality Assurance & Regulatory Affairs