The Quality Manufacturing Engineer will be responsible for a variety of Quality Assurance activities related to coated product and process improvement. Specific functional areas include, but are not limited to design and execution of DOEs, qualifications and validations.
The Sr. Quality Assurance Engineer will work to ensure that all customer and company standards have been met with exceptional quality and reliability results. In this role, there is a responsibility to support supplier quality and all aspects of the manufacturing process.
Provide quality engineering support for OPM sponsored clinical trial monitoring, including; a. Select, audit, approve new clinical trial sites b. Provide, or assist with, the monitoring plan c. Provide or assist in clinical trial site readiness audits and training for regulatory health agency inspection.
Responsible for defining and monitoring quality inspection requirements of components and systems, at incoming and with the supplier/sub-tier from their incoming/in-process/final/test along with technical guidance on testing requirements.
Work closely with peers to develop appropriate qualifications, validations, inspection plans and gauging including reliability assessment for both new design and changes to released product. Assure the resolution of all issues raised by the testing.
Monitor and determine actions for first pass yield reports, scrap reports, and process audit reports.Analyze customer complaints and field failures.Coordinate corrective action, follow-up and reporting.