Quality Assurance Specialist
Station Island, California
Expiry Date :
Sat, 07 Nov 2020 23:59:59 GMT
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The QA Specialist is an experienced person within the medical device industry with knowledge performing their function within the FDA Quality System Regulations (QSRs), ISO 13485:2003, and MOD. The QA Specialist has the ability to perform various quality assurance duties under minimal supervision and to work in accordance with THINK Surgical, Inc. Standard Operating Procedures (SOPs).
* Perform Device History Record review and release functions
* Review certificates of compliance or test reports
* Review receiving inspection documentation
* Report non-conformances and discrepancies
* Perform, in-process and final inspections in accordance with written procedures, statistical sampling plans, engineering drawing and specifications.
* Perform a wide range of complex or precision inspection procedures to determine quality levels of parts or products at various stages in production, including final acceptance,
* Maintain and operate inspection and test equipment (e.g., optical measurement system, micrometer, caliper, pin gages, microscope, tensile tester, etc,)
* Perform first article inspection and informs appropriate personnel of results,
* Assist in the analysis and reporting of SPC data,
* Provide technical quality support to the Manufacturing/Operations engineer(s)
* Ensure the traceability of components and products are maintained at every inspection points.
* Document, file, and maintain all inspection documents.
* Create and modify documents contained in the Quality System, such as manufacturing procedures, forms, standard operating procedures, and initiate DCOs, as appropriate.
* Participate in internal audits and audits by regulatory bodies (e.g. FDA, Notified Body).
* Responsible for implementing assigned corrective actions and NCMRs.
* Executes other quality projects and non-routine duties as assigned by the QA manager.