The company needs to ensure the quality and conformance of incoming raw materials, components, and packaging used in medical device manufacturing by performing inspections and testing.
Requirements
- Able to read and comprehend specifications, schematic drawing procedure and related forms of information in English.
- Experience in an ISO 9001, ISO 13485 or other regulated work environments a plus.
- 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, eQMS experience a plus.
- Perform identification and functional testing of product by use of calibrated test equipment.
- Ensure calibration status of instruments in IQA lab is current prior to use and is meeting predetermined requirements.
Responsibilities
- 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.
- Completion of 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.
Other
- Associate degree is preferred. Minimum 3 years of work experience in a quality control function.
- Strong attention to detail, problem solving skills and responsible decision making.
- Able to lift up to 35 lbs.
- 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.
- Office, warehouse and clean room environments that may include moderate noise levels and required appropriate PPE and cleanroom apparel as necessary
