· Quality Technician position for the manufacturing and assembly of Neurosurgery medical devices. The Quality Technician will function as technical support for the Quality Management System, including development of quality inspection procedures, setup of incoming component measuring equipment, maintenance of records of inspection and nonconforming materials program.
· Will perform a variety of inspection and testing duties including, but not limited to, mechanical inspection (dimensional, visual, and functional).
· To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
· Perform and document tests and inspections on incoming materials and finished product, sterile and non-sterile, per the applicable procedures and or instructions, using various measuring equipment and tools to ensure conformance to standards.
· Perform and document first article inspections.
· Help develop and document quality plans, inspection criteria and inspection methods.
· Gather supplier data.
· Review test data to ensure compliance to applicable specifications; document and report all abnormalities.
· Review and confirm discrepant parts and products reported from production and testing.
· Generate Material Review Reports for non-conforming product and make recommendations for corrective and preventive actions.
· Identify and review non-conformances to related QA/RA requirements (QSR, GMP, MDD, ISO13485:2016)
· Perform Receiving and In-Process inspections per applicable procedures and accurately document findings/results.
· Perform DHR/BOM/Work Order reviews to ensure accuracy and completeness.
· Determine correct inspection sample size per the various AQL levels required by the applicable procedures.
· Review test reports received from outside laboratories to ensure acceptance criteria are met and to determine when product has met the requirements and is acceptable for release.
· Exercise judgment within defined procedures and/or instructions to determine appropriate action.
· Maintain complete and accurate records for all DHR/BOM/Work Orders, lab test results and reports.
· Complete all paperwork and authorize release of incoming and or in process product.
· Apply knowledge of Good Manufacturing Practices on a daily basis.
- Perform duties required in a timely manner to meet departmental and company deadlines
· Minimum of five (5) years on the job experience in the related field, with formal technical education or training
· Minimum five (5) years inspection experience in the Medical Device industry
· Able to interpret process documentation, specification and drawings
· Familiar with ISO 13485, FDA 21 CFR 820, CMDR
· Demonstrated skills in Supplier Quality Management
· Experience in the use of mechanical, optical and Automated measurement gages.
· Experience in Machining operation will be a plus