Quality Engineer

MAJOR DUTIES AND RESPONSIBILITIES:

* Maintain current knowledge of federal and state regulations regarding QSR, ISO and quality assurance issues.
* Provide quality guidance in cross-functional settings.
* Serve as the quality team member on development projects, provide project guidance with support from management, and assist with design history deliverables such as developing and executing protocols for testing (e.g. design verification, process validation)
* Participate in the development and update of quality procedures (e.g. SOPs).
* Participate in 3rd party, supplier, and internal audits.
* Proactively champion quality assurance continuous improvement initiatives where applicable in company-wide activities, including design control and manufacturing. Support company goals and objectives.
* Supervise quality inspection functions, such as receiving inspection, in process inspection, and final product release.
* Hire, train, and supervise technicians and inspectors.
* Provide project direction and mentoring for more junior team members.
* Support Document Control function including change control, training, and maintaining quality records and documents.
* Support databases for product complaints, corrective & preventive actions (CAPA), NCMRs, and other quality systems.
* Carry out investigations for complaints, returned goods failure analysis, nonconforming material reports, and CAPA resulting in appropriate corrective actions that improve quality system and device safety and effectiveness.
* Apply sound statistical methods to data analysis activities (e.g. CAPA, SPC, complaint trends, validations, risk analysis)
* Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
* Participate in the function of the Change Control Board as a quality signatory.
* Administrate quality functions such as the Material Review Board and the supplier quality system.
* Thoroughly document all issues related to quality assurance, QSR, and ISO compliance.
* Plan, schedule, and complete projects in a manner consistent with corporate objectives.
* Track and maintain metrics for Management Review of the quality system.
* Proactively communicate project status to management.To find out more about Real Staffing please visit www.realstaffing.com