Lead Quality Systems Auditor

Lead Quality Systems Auditor

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 and with gap analysis for projects or local QM implementations
• As a SME, serve as the primary support for inspection readiness, ensuring sites are well-prepared for inspections
• Support training and qualification initiatives for new auditors, ensuring they are adequately prepared to conduct internal audits in accordance with FME policies and procedures
• Performs other related duties as assigned

Physical Demands and Working Conditions:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Requires significant travel (approximately 30% - 50%).
• May be exposed to infectious and contagious diseases/materials.

Experience and Skills:

• Bachelor's degree or an equivalent combination of education and experience required (advanced degree preferred)
• 3rd party auditor training (e.g. ASQ-CQA, ASQ-CBA, RABQSA, ISO 9001:2015) or equivalent education and experience required
• Minimum 10+ years' experience in quality management, regulatory compliance, quality engineering and auditing in the pharmaceutical or medical device sector or related industries
• Several years of practical experience in FDA inspections and cooperation with US regulatory authorities (experience with additional Health Authorities preferred)
• Knowledge of current regulations for pharmaceutical and medical devices (e.g., 21 CFR Part 820, Part 210/211, Part 11, Part 803, Part 806, Canadian SOR/98-282, Mexican NOM-241-SSA1, MDSAP, CE Marking) required
• Knowledge of current standards and guidelines for pharmaceutical and medical devices (e.g., ISO 13485, ICH Q7/Q10, ISO 14971, ISO 10993, IE 62366, GxP) required
• In-depth knowledge in the interpretation of FDA guidelines, Good Manufacturing Practices (GMP) and relevant quality standards for pharmaceuticals and medical devices
• Expertise in reviewing, revising, and writing Standard Operating Procedures (recent auditing expertise preferred)
• Demonstrated expertise in specialized processes related to drug and device manufacturing, particularly in areas of sterilization, bag manufacturing, NC/CAPA, corrections and removals and formulation (experience outside of auditing/inspecting desired)
• Profound experience with best practices in product design / design change, risk management and CAPA management
• Demonstrated broad expertise related to the principles and application of quality conformity and regulatory compliance
• Strong analytical and conceptual skills
• Ability to identify risks and compliance gaps and develop appropriate actions
• Strong problem-solving skills
• Experience in training and mentoring staff
• Excellent communication and writing skills when interacting with interdisciplinary teams, international authorities and other stakeholders
• Ability to work both independently with direction and within project teams to attain goals
• High level of commitment, flexibility and sense of responsibility
• Willingness to travel internationally
• Proficiency in using Microsoft Office applications required