Quality Systems Lead Inspector

PURPOSE AND SCOPE:

The Quality Systems Lead Inspector ensures Quality Systems presence on the manufacturing floor.  Responsible for inspection of raw materials, parts components, assemblies and/or finished products.

Ensures conformity to established standards, specifications and drawings through the use of precision measuring equipment, tests and visual standards.

PRINCIPAL DUTIES AND RESPONSIBILITIES:


* Leads the coordination of inspection activities with other Inspectors to ensure the work is performed properly under established company policies and procedures.


* Prepares, performs, and controls raw material/packaging material incoming inspections and Material Inspection Records.


* Assigns lot control identification to all incoming production components (chemical components, packaging components, etc.).


* Samples and inspects packaging and chemical components according to approved procedures to ensure conformance with specifications.


* Verifies and records the receipt of components and their condition upon arrival.

Documents condition of nonconforming components (description, photographs, etc.) for Material Review Board (MRB) disposition.


* Performs and maintains process ownership of supplier evaluation activities.


* Maintains effective and professional communication with external vendors/suppliers.


* Assists in scheduling inspection staff and coordinating work activities of the Inspectors


* Participates in cross functional failure investigations and facilitate root cause analysis.


* Leads in the performance and maintenance of calibration services and activities for inspection tools.


* Monitors status of work in progress within the department, assuring the completion of work and issuing of required reports in a timely manner.


* Reviews quality/production records for accuracy, completeness, and conformance to all applicable procedures.


* Presents inspection orientation and verifies adequacy of inspection training for new Inspectors.


* Performs inspections/audits of the process to ensure conformance with SOP procedures and identification as needed.


* Prepares, issues, and reconciles all finished product labels in accordance with established label control procedures.

Prepares samples for internal laboratory testing or for shipment to an appropriate testing facility.


* Records, counts, and interfaces with issuing facility, and maintains/adjusts the label inventory as necessary.


* Receives and inspects the incoming product labels.


* Enters data in spreadsheets, as assigned for QS records and trending.


* Assists with validations as required.


* Maintains a clean inspection work area.


* Assists with the testing of raw materials in the Chemistry Lab.


* Assembles device history records (DHR) for issuance to production.


* Leads the coordination and performs reviews of finished DHR's for completeness and correctness.


* Responsible f...