Principal Quality Auditor for Zimmer Biomet in Warsaw, IN
Some responsibilities include:
The primary job responsibility for this position is to audit Zimmer’s worldwide Quality Systems and processes for compliance to the applicable company policies and procedures, the Quality System Regulation (21 CFR Part 820), ISO 13485:2003, the Medical Device Directives (MDD), and all other applicable standards and regulations.
Principal Duties and Responsibilities
Plan audits by preparing and communicating audit plans. Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews of employees for compliance.
Communicate audit results through the preparation and publication of audit reports. Follow-up audit results by seeking appropriate corrective actions if deficiencies are noted.
Track implementation of corrective actions and verify actions for effectiveness. Support management on tracking audit activities and administration of audit schedule.
Support external audits including interfacing with regulatory agencies and registrars if necessary. Lead and support projects and initiatives to achieve Quality Systems objectives and any other regulatory objectives (e.g., QSR training, Quality Systems initiatives, etc).
Expected Areas of Competence
Must be familiar with all aspects and elements of a quality system including but not limited to corrective and preventive action (CAPA), management responsibility, product realization and measurement, analysis and improvement processes.
Must have basic knowledge of manufacturing processes and the ability to work towards in-depth understanding of Zimmer processes and products.
A strong background in math, chemistry, engineering or microbiology is desirable to enable the individual to evaluate systems such as machining, sterilization, electrochemical processes, statistical process data, etc.
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