Senior Advanced Quality Engineer - (US-RI-Providence - 02940)

Minimum Education: None
Jobcode: L:102489802
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Overview:


This position reports to Manager, Advanced Quality Engineering and is responsible for assuring that new product designs and processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy as well as represent quality interests and concerns on project teams.


Responsibilities:


·Provide technical guidance to Quality Technicians and Inspectors. ·Development of Test Protocols and a Final Report to support 510K or PMA submissions. ·Development of the DFMEA, coordinating input from the other Design Sub-team members. ·Development of the Final Design Verification Protocol and the subsequent Final Design Verification Report including an analysis of all data and a decision on design acceptability. ·Provide input into the project Product Performance Specification (PPS) and Product Development Plan (PDP). ·Determination the degree of Biocompatibility testing required on a project. Co-ordinate the testing at an outside lab and document results. ·Develop or assist in developing test methods for the specifications listed in the PPS. ·Develop test protocols and release a final report on Shelf Life Studies in support of expiration dating. ·Develop and document the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product. ·Development of the PFMEA, coordinating input from the Manufacturing Engineer. ·Perform Process Validation Studies to determine the acceptability of new processes or equipment. ·Design and qualify inspection and test equipment. ·Make dispositions of rejected nonconforming components and products; conduct MRB action when required. ·Organize and generate detailed quality information reports to show trends and the impact of process improvements. ·Support Process Transfers to the production facilities. ·Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering. ·Perform DOE’s and other statistical tests to support product and process optimization or determine causes of quality nonconformance. Initiate corrective actions as required. ·Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted. ·Support goals of the Quality Assurance Department. ·Some travel is required.


Qualifications:


·Bachelor’s Degree in Engineering or Technical Sciences. ·A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability etc. ·3 years minimum experience in quality engineering including product/process validation and technical problem solving in the medical products industry. ·Good oral and written communication skills. ·Knowledge of FDA QSR’s, ISO13485:2003, and ISO 9001:2000. ·Knowledge and Application of Six Sigma/Process Excellence Tools. Green Belt/Black Belt Certification a plus.