Lead Quality Systems Auditor

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Fresenius Medical Care (FMC) is a people business.

Our success depends on having the best and brightest employees and helping them attain their personal and professional goals while delivering excellence in patient care and business results.

Our employees embody our culture which is based on six core values supporting our promise to improve the quality of life of every patient every day.

These core values are, Patients and Partners First, Honesty and Integrity, Quality and Compliance, Collaboration, No-Limits Mindset and Results Oriented.

PURPOSE AND SCOPE:

Lead Quality Systems Auditor will act as a Subject Matter Expert (SME) in inspection activities for Quality System (QM) audits required by the corporate quality systems audit program, including planning, preparation, execution, follow-up, closure, and trend analysis.

Responsible for continuous improvement of the audit program with an emphasis on maintaining compliance with applicable regulations, standards, and pertinent Fresenius Medical Care policies and procedures to drive continuous quality improvement.

Support external quality management inspections at Fresenius Medical Care sites and distribution centers as SME, including preparation, conduct and follow-up, and coordinate with various sites and local quality heads, to ensuring readiness for inspections.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  


* Responsible for quality systems audits, schedules, plans, conducts, and leads audits in accordance with the global QS audit program


* Lead and manage internal and corporate audit program for all assigned sites, with a focus on planning, scheduling, and implementation in close coordination with sites and local quality heads


* Perform QM audits required by the corporate quality systems audit program, including planning, preparation, execution, follow-up, closure, and trend analysis


* Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.

Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results


* Ensures audit activities are in compliance with FME policies and procedures and applicable regulatory requirements


* Develop and maintain audit processes and documentation to ensure conformity with FME policies and procedures and compliance with applicable regulations


* Track, manage, and resolve Non-Conformances (NC’s) and Corrective and Preventive Actions (CAPAs) arising from audits


* Provide status reports on overdue, open, and closed audit outcomes to relevant stakeholders


* Recommend modifications to existing quality or production systems to optimize product quality while ensuring compliance with regulatory requirements and internal Fresenius procedures


* As a SME, support FME sites a...