Experience Requirements
Previous medical device or pharmaceutical experience required. Must have FDA regulated environment experience. Previous quality management experience a must.
Qualification Requirements
5-8 Years experience in Quality Assurance management with a medical device or pharmaceutical manufacturer.
Preferred Qualifications
Extensive FDA experience in medical device or pharmaceutical setting.
Responsibilities
Prepare, submit and trend all reportable customer complaints to the FDA as specified in the Medical Device Reporting Regulation, and if applicable, international compliance reports to EI correspondent authorities. Maintain the official customer MDR files. Serve as Everett facilities management representative for puposes of CE/ISO certification and ongoing compliance. Develop and maintain an effective organization through selection , training, compensation and motivation of all assigned personnel. Control the Everett calibration. Analyze and investigate cardiac assist product complaints and report trends for all company product lines to top management. Control inspection, salvage, and reprocessing of customer returns. Review and approve all produc and process specifications including final approval of device history records of Everett components. Approve and maintain document files for all active experimental products. Confer with engineering and manufacturing personnel and in conjunction with them resolve problems of product design, specifications, materials, tooling, and production operations affecting quality. Audit the plant for conformance with FDA Good Manufacturing Practices. Adhere to and ensure the compliance of all Company policies, rules, procedures, and housekeeping standards
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