Quality Assurance Technician
Summary
Perform quality inspections and tests on implantable medical devices, review records, and assist in non-conformance resolution using specialized equipment.
Description:
- Provide support in production-line Quality inspections for implantable medical device (heart valve)
- Provide support in execution of inspection and/or test procedures to evaluate all aspects of development of new products.
- Provide support in review of Quality records such as Device History Records of product sub-assemblies and/or finished goods.
- Provide support in Quality inspections of supplied medical device components and associated record keeping.
- Assist Quality Assurance team in remedial actions to support disposition of product or component non-conformance
- Assist in environmental monitoring processes and associated record keeping.
- Operate specialized equipment that supports established test and/or cleaning activities.
Skills:
- Ability to read manufacturing prints and identify associated specifications/characteristics related to inspection and testing to be performed
- Ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection system
- Ability to use computer and general office software for data entry
Requirements:
- AA degree or equivalent directly transferrable work experience
- Minimum of 3 years of professional experience working in a Class III medical device manufacturing environment