The Quality Auditor is responsible for the management of the audit system at the client.This role plays a key part in the establishment of a global and harmonized Quality System. In addition the role is responsible for improving, monitoring, and reporting on the effectiveness of the Quality Management System, management of the internal auditing team, the establishment and maintenance of a global audit practice, implementation and maintenance of quality system compliance training across the organization and continued improvement in the auditing and CAPA systems.
Establishes implements and manages objective, ethically based internal audit programs using and interpreting applicable standards/requirements. Develops audit plans to ensure regulatory compliance. Is a leader and primary trainer in the organization regarding audit specifications, regulatory requirements related to the quality system and appropriate audit etiquette. Creates and leads multidisciplinary teams to complete audits, identifying and prioritizing required resources. Identifies and analyzes the benefits, costs and implementation of audit programs. Creates internal audit reports and corrective action plans and establishes a structure to review audit findings and ensure effective remedial measures are agreed upon, implemented, and documented. Determines appropriate action and provides leadership for the systemic improvement in the quality system as a result of audit findings.
Manages audit findings in the CAPA system to ensure that corrective and/or preventive action is effective and does not have an adverse effect on the device, including defining methods for determining verification or validation of both corrective and preventive action, implementation planning for recording changes in methods and procedures, and defining methods for disseminating information on the quality problem or nonconforming product to those responsible. Evaluate proposed corrective-action plans on the basis of established criteria, such as contractual or procedural compliance. Recognize unacceptable corrective- action plans and use various negotiation techniques to improve them. Confirm that corrective action has been implemented as agreed. Provides training and mentoring of technical personnel, as needed.
Leads the organization in the establishment and implementation of procedures for preparing, conducting and responding to external audits. Trains employees on appropriate conduct during external audits. Creates and leads a multidisciplinary team system for responding to external audit observations and, within defined timelines and schedules, provide written responses to audit observations by regulatory authorities. Prepares and analyzes audit CAPA metrics, makes improvements to audit CAPA processes and presents information to senior management as needed. Monitors work to ensure quality, and continuously promote Quality First Time.
May perform other duties as required in the management of the Quality System
Source: Job Diva – Job Listing