Quality Inspector III

Job Description

Job Description

SUMMARY OF POSITION :

Reporting to Department Manager, this position will have direct responsibility for the quality control functions within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation and / or perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

ESSENTIAL FUNCTIONS :

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Train and perform inspections on machined components, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers, and gages.
• Train and perform further complex inspections on machined components utilizing methods such as comparators, CMM and / or various manual and automated techniques.
• Demonstrate team leadership, train, and provide guidance to Quality Control personnel.
• Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
• Creates, completes, and compiles necessary documentation related to Quality Inspection standards.
• Provide basic programming assistance for complex inspection / test methods, as required.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Accurately review and ensure Good Document Practices (GDP) are upheld for Routers / Inspection Plans / Device History Records (DHRs) throughout the manufacturing process and in preparation for final lot release / shipment.
• Support Quality Best Practices and GDP / GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.
• Generate Packing Slips and Certificates of Compliance (C of C) in accordance with TOMZ and / or customer requirements.
• Support physical and / or electronic record retention.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Support other Quality Department functions, as needed.
• Other duties and responsibilities are assigned

QUALIFICATIONS : Education

Experience

Qualifications