Quality Assurance Inspector

A medical device client in the Clear Lake area is looking for a Quality Inspector to join their team. This position is responsible for performing incoming inspections on raw components used during manufacturing of in-process subassemblies and finished products. The products they manufacture are Neuromodulation devices and Cardiopulmonary devices.

This is all incoming components for our clients’ devices they manufacture. 90% of product that comes into their building is required to go through inspections for confirmation for specifications of the vendors. The equipment that they use varies. Calibers, micrometers, gauges, and some visual tools. An inspection can take a whole day for one part, because they are tedious and detailed. Each item has its own specifications sheet that the team has to follow strictly step by step. It’s tedious and they must be quality focus, patient and have attention to detail.

Must Haves:

• High school graduate or equivalent
• Exposure to ISO/FDA regulations, Quality Inspection Techniques and Workmanship Standards
• 2 years of experience with QA experience / quality control / inspection
• Proficiency in MS Office (basic)
• Good verbal and written communication skills
• Attention to detail
• Medical device or Aerospace industry experience

PRIMARY ACTIVITIES

• Inspects or tests components and raw material according to written inspection procedures
• Inspects electronic or mechanical assemblies, subassemblies, and component parts for compliance with acceptance criteria as defined by specifications, drawings, samples, or illustrations
• Examines units visually, with microscope or other magnifying device, to determine physical defects according to written inspection procedures.
• Compares assemblies with drawings, parts lists, illustrations, and/or samples to verify conformance and detect assembly errors
• Examines the alignment of parts and verifies installation of hardware on assemblies and subassemblies
• Measures parts for conformance to specified dimensions using measuring instruments or equipment
• Accepts or rejects materials / product inspected based on conformance to acceptance criteria
• Records inspection data on appropriate forms, logs, and/or in computer databases
• Maintains controlled document files and test records in a timely and accurate manner
• Coordinates calibration of all test equipment and fixtures
• Monitors critical equipment and instrumentation to ensure proper operation and calibration
• Identifies and controls nonconforming material and defective products until the material has been quarantined
• Responsible for identifying, evaluating, recording, and initiating correction or prevention of quality related problems
• Responsible for identifying and controlling nonconforming material and defective products by segregation or product identification
• Performs other duties as may be required by management

ADDITIONAL ACTIVITIES

• Authorized to accept or reject materials / product based upon conformance to acceptance criteria
• Authorized to segregate and quarantine nonconforming materials/product
• Authorized to identify and report non-conformances in materials, components, products, processes, equipment, facilities, and other parts of the quality system.
• Authorized to initiate corrective action.
• Authorized to identify and initiate corrective action of non-conformances in documentation, design, equipment, facilities, processes, including those activities covered by the Quality System.
• Authorized to identify non-conformances in documentation, design, equipment, facilities, processes