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
- 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.
Supervision: Supervised by Manager of Quality Assurance & Regulatory Affairs