Quality Control Inspector I

The Quality Control Inspector is responsible for performing routine inspections of components, subassemblies, and finished products to ensure compliance with approved drawings, specifications, inspection plans, and regulatory requirements. This role supports product quality, safety, and effectiveness while maintaining compliance with current Good Manufacturing Practices (cGMP), FDA Quality System Regulations (21 CFR 820), and other applicable quality standards.  This position will also assist the Document Control Coordinator in creating, reviewing, routing and controlling document changes per established procedures.

Essential Functions & Accountabilities:

• Perform routine and detailed inspections of incoming materials, in-process goods, and finished products.

• Conduct visual, dimensional, mechanical, and functional inspection using approved methods, tools, and equipment.

• Ensure components, subassemblies, and finished products comply with approved company drawings and specifications. 

• Document inspection results to ensure full traceability. 

• Identify, document, and report defects or nonconformances (NCMRs) and determine disposition of product (accept, reject, rework, return to vendor) in accordance with approved company procedures.

• Support site DCC with creation of COCs and COAs 

• Assists Document Control Coordinator for controlled document changes and place them in Controlled floor locations
• Assists with upkeep of training records, Calibration records and with third party audits, supporting management with documentation as needed.
• Reviews and approves certification of conformance at incoming inspection location and scans them into MasterControl.
• Scans completed DHRs for electronic record retention.

• Perform other duties as assigned.