Compliance Specialist I

Our client is a leading OEM supplier of products and services for medical devices and procedures.

The primary purpose of this position is to execute and support implementation of the following:  Complaint Handling, MDR and Vigilance reporting, CAPA, Field Action execution, and Compliance Consulting for Greatbatch manufacturing facilities, under the direction of the Global Quality Systems and Compliance Program Manager. This position will also be responsible for participating in development of processes that comply with national and global regulatory requirements.  This position may also conduct detailed quality analysis and trending of data. 

Bachelor’s degree or equivalent related work experience required.  3-5 years within Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or Diagnostics industry.   Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485).  Problem Solving and training skills.   Proficient in Microsoft Office applications required.  Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired.

Responsible for performing complaint investigations including: documentation of complaint, working with manufacturing facilities to complete complaint investigations, and determining need to escalate issues. Coordinate MDR and Adverse Event reporting activities. Participates in CAPA compliance activities for the enterprise CAPA board. Supports execution of field actions including: reconciliation of returned products, monthly status reporting, and oversight of corrective actions. Provides Quality Systems and Compliance consulting to manufacturing sites related to CAPA, Complaint Investigations, and other compliance topics. Coordinates and supports Quality Audit activities including audit and inspection preparation. Responsible for metrics coordination and reporting. Plays an active role in development and maintenance of the Enterprise Quality Management System under the direction of the Global Quality Systems and Compliance Program Manager and the QS Director. Independently performs assignments, receiving instruction only regarding general expected results. Performs other functions as required.