Quality Assurance Inspector
hace 2 días
Main Objectives of the Role
The primary goal of this position is to perform thorough inspections and testing of acquired materials, components, and products in accordance with established policies and procedures. Additionally, this role will provide technical inspection support to Supplier Quality Engineering as needed.
Key Responsibilities:
- Conduct visual, dimensional, and functional inspections and testing in adherence to documented policies and procedures.
- Record inspection and test data accurately as prescribed by written instructions and procedures.
- Operate all associated test and measurement equipment according to documented instructions and procedures.
- Develop new inspection methods and improve existing ones.
- Ability to program Coordinate Measuring Machines (CMMs) and Optical systems.
- Recommend and propose changes to policies, procedures, and specifications as necessary.
- Document non-conformances in the Non-Conforming Material Review system.
- Design and conduct Gauge R&R studies to ensure accuracy and reliability.
- Collect, analyze, and present data for First Article inspections.
- Perform testing and inspection in accordance with special test requests.
- Contribute to the selection and acquisition of test and measurement equipment.
- Train other inspection staff on the use of complex inspection equipment.
- Request certifications from vendors as required.
- Discuss inspection methodology with suppliers to achieve correlation of inspection data.
- Assist in gathering, analyzing, and trending of data.
Required Education and Experience
A High School degree is a minimum requirement. However, 3+ years of experience in Quality performing inspections or equivalent internship experience in the Receiving Inspection area are preferred. The ideal candidate should possess intermediate command of English and have prior medical device component inspection experience.
Preferred Qualifications and Education
In addition to the above requirements, candidates with experience in CMMs, optical measurement equipment, hand tools, gages, pressure and force gauge testing are highly desirable. ASQ CMI certification and knowledge of FDA, GMP, and ISO 13485 regulations are also beneficial. A technical degree in Mechanical Engineering or a related field is preferred, as well as experience with SAP software.
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