Quality Engineer

Details: The primary purpose of this job is to execute and support the Complaint Handling and regulatory reporting processes under the direction of the Quality Systems Engineer. This position will also be responsible for participating in development of processes that comply with published regulatory requirements. This position will also conduct detailed quality analysis and trending of data. Key Accountabilities and Responsibilities Adheres to Greatbatch Core Beliefs and all safety and quality requirements. Responsible for supporting and performing customer complaint investigations by working in collaboration with Operations, Quality and R&D associates to facilitate the completion of complaint investigations in a timely manner and determining need to escalate issues. Reviews test procedures and plans related to complaint investigations prior to executions, conducts failure analysis and inspection on products, processes and materials Responsible for completion of Medical Device Reports (MDRs) and Medical Vigilance Reports (MDVs) determination checklists. Responsible for completion of applicable forms for submission of reportable complaints to applicable agencies. Responsibly for metrics coordination and reporting to manager. Provides Quality Systems and Compliance consulting to Operations associates related to Complaint Investigations, and other compliance topics. Independently performs assignments, receiving instruction only regarding general expected results. Assists with quality assurance functions in support of needs directed by Quality Management. Performs other functions as required. Job Requirements Minimum Education: Bachelor's degree in a related field or equivalent amount of work experience Specialized Knowledge: Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485),preferred. Problem Solving and training skills. Special Skills: Proficient in Microsoft Office applications required. Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired.
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