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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
- 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
- Certificates Licenses and Registrations
- ASQ CQI (Certified Quality Inspector) preferred
- 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.
Supervised by Manager of Quality Assurance & Regulatory Affairs