Quality Control Supervisor

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

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