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Quality Specialist
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- The Quality Specialist will maintain quality assurance programs, procedures and controls, ensuring that finished devices are inspected and/or reviewed to ensure they meet medical device requirements and are of the highest quality standards prior to release for sale.
- This role will also be responsible to ensure that sophisticated device history records DHR are maintained in an organized manner and able to be assembled quickly for audit purposes.
- Review of production, packaging/labeling and laboratory documents for final product release Assemble device history records
- Scan and/or prepare DHRs for Archive and offsite scanning and ensure legibility and accuracy of electronic storage
- Participate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problems
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