Quality Control Inspector

The appropriate candidate will perform receiving inspection of component parts as well as in-process and final inspection of device assemblies. This individual will have mastery of a wide range of inspection tools and equipment. The quality control inspector will be responsible for receiving parts into the facility, maintaining control and status of parts prior to inventory and independently determining product acceptance to specifications. They will maintain the documentation necessary for the device history record (DHR). They will assist with the validation of measurement and test methods. The quality control inspector will also partner with engineering for prototype assessment and to recommend improvements to specifications.

Responsibilities

·  Perform receiving inspection as directed on engineering drawings in order to qualify components for release to production inventory.

·  Perform in-process and final QC checks according to quality inspection procedures in order to determine the acceptance of device subassemblies and finished goods.  

·  Maintain the receiving inspection records and files.

·  Recommend and develop measurement methods for complex dimensional specifications.

·  Partner with development engineers to identify inspection difficulties and correct them.

·  Perform gage repeatability and reproducibility studies (GR&R) to assure measurement methods are appropriate.

·  Ensure that gages and inspection equipment are maintained and calibrated.

·  Monitor supplier performance by their part quality and identify supplier corrective action opportunities.

·  Handle materials in accordance with established procedures to prevent mix-ups, damage or other adverse events.

·  Maintain traceability of components and materials to their receiving data.

·  Identify measurement capability deficiencies and recommend / procure new measurement tools as needed.

Qualification Required

·  Vocational or technology degree (2 yr. acceptable) with 3 to 5 years experience in an inspection capacity.

·  Must be able to read engineering drawings and understand GD&T callouts.

·  Must be able to use all standard hand inspection tools, gages and optical comparator. Experience with vision systems and CMM desirable. Working experience with the FARO GagePlus is a plus.

·  ASQ Certified Mechanical Inspector preferred.

·  Must be computer literate and know Microsoft Office, Excel and Outlook.

·  Must be familiar with ANSI/ASQ sampling procedures and tables for inspection.

Knowledge of FDA Quality System Regulations or ISO 9000 and previous experience with medical device manufacturing companies is a plus.