Sr. Compliance Auditor - (US-IL-Chicago - 60827)

Minimum Education: None
Job Type: Full Time
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Responsibilities : This individual will perform internal audits, assessments, and analysis of medical device and diagnostic quality systems and operational areas. This individual will also provide direction and consultation on the application of medical device regulations and risk management across total product life cycles. In addition, our chosen candidate will help ensure Abbott products are developed and manufactured in accordance with Abbott policies and standards, which reflect quality and regulatory requirements, along with recommending audit corrective actions and best practices. This individual must achieve a difficult balance of involvement and objectivity, perform risk analysis, and prioritize key issues. This function assesses compliance of Abbott quality/business systems to applicable regulations, standards and corporate policies. It serves to protect Abbott stakeholders by providing gap analyses, recommendations, and assurance that priorities are addressed based on risks/benefits. This service must be provided in an objective manner. A strategic focus on emerging regulations and their potential impact on Abbott is essential to success in this role.

Requirements :Basic

Requirements : All candidates must possess a Bachelor Degree either in the Biological Sciences or Engineering. Candidates must possess a minimum of six to ten years of Quality Assurance or Compliance Audit in the medical device industry, preferably with one to two years in a supervisory capacity. Candidates must have a fundamental understanding of quality systems as related to one or more of the following areas: sterile medical ophthalmic products, sterile product manufacturing, instrumentation manufacturing, computer-controlled products/processes, vascular devices, glucose monitoring, or general medical devices. In-depth knowledge of medical device and diagnostic regulations and related operations, along with the ability to assess compliance and recommend solutions, is essential. Our final candidate must have excellent oral/written communication skills, which include tact, open-mindedness, maturity, tenacity, decisiveness, self-reliance and sound judgment.

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