Incoming Quality Inspector (R9-Days)

Job Description
Position Purpose: Perform inspection of incoming components and raw materials ensuring compliance with internal and customers established standards.
KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:
· Responsible for the incoming inspection of raw materials, components and packaging utilized in medical device
manufacturing, to determine conformance to approved specification and test requirements.
· Read and interpret part drawings, have basic mathematical skills and utilization of measuring instruments.
· Ability to follow test procedures, perform visual inspections, identify variations against standards, colors and textures.
· Collect or select samples for testing, evaluation or as retain samples.
· Perform incoming inspection documentation review and approval to ensure compliance to procedures and good
documentation practices.
· Confirm material/component identification and complete functional testing of product.
· Read and interpret part drawling, data, manuals, and other materials to determine specifications, inspection and
testing procedures, and measuring instruments required for inspection.
· Initiate rejection for nonconforming materials, which do not meet specifications.
· Initiate or assist Supplier Quality Manager in creating SCAR for rejected supplier related materials as required.
· Discuss visual and dimensional inspection results with Supply Chain personnel and provide supporting information in a
timely manner.
· Initiate hold status and or rejection in SAP for nonconforming materials, which do not meet specifications.
· Provide documentation, samples and test results to Supplier Quality Manager for nonconformances/ SCAR events .
· Maintain, review, and approve records, documentation and retain samples per procedural guidelines.
· Discuss visual and dimensional inspection results with other department personnel and provide supporting
information in a timely manner to assist in final product disposition.
· Assists Supplier Quality Manager and production Quality Managers in coordinating and executing objectives
throughout the company in cooperation with other employees, to maximize product quality and operating system
efficiency/effectiveness to minimize costs.
· Support and comply with all policies of the company including but not limited to cGMP, ISO Standards, Health and
Safety Requirements and Continuous Improvement as well as standard work procedures.
· Perform identification and functional testing of product.
· Generate labels to identify material of acceptance, hold or rejection status.
· Notify Supplier Quality Manager, Buyer/Planner, and other appropriate personnel by email communication when
nonconformances are identified.
· Ensure calibration status of instruments in IQA lab is current prior to use and is meeting predetermined
requirements. Awareness to notify Metrology department if service or calibration is required.
· Other duties as assigned.
POSITION REQUIREMENTS:
· Associate degree is preferred. Minimum 3 years of work experience in a quality control function.
· Able to read and comprehend specifications, schematic drawing procedure and related forms of information in
English.
· Strong attention to detail, problem solving skills and responsible decision making.
· Experience in an ISO 9001 work environment a plus.
· Able to lift up to 35 lbs.
PREFERRED KNOWLEDGE/SKILLS:
· Basic computer skills. Word, Excel, PowerPoint and corporate network navigation.
· Ability to read and interpret simple mechanical drawings, schematics and follow laboratory test instructions.
· SAP experience desired.
WORK ENVIRONMENT:
· Office, warehouse and clean room environments that may include moderate noise levels and required appropriate PPE and cleanroom apparel as necessary.