Global Quality Systems Leader Medical Devices Compliance

Fresenius Kabi USA, LLC; Warrendale (Allegheny County); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401K with company contribution

Wellness program

Life insurance

Disability coverage

Job summary

Fresenius Kabi USA, LLC in Warrendale seeks a seasoned Quality Compliance Leader to shape and drive the global quality program for a distributed medical device portfolio. The role emphasizes strategic development of compliant quality systems and effective collaboration across units.

You will manage regulatory audits, monitor inspection readiness, and coordinate with global Quality Units to ensure ongoing regulatory compliance and robust quality performance.

Qualifications

• Bachelor's degree in a life science, engineering, physical science or related discipline.
• 8–10 years of experience with in-depth knowledge of the regulatory environment for medical devices (global products).
• Lead Auditor or ASQ certification highly desired (e.g., ISO 9001/13485 lead auditor).
• Experience dealing with FDA inspectors and other regulators during quality system audits; Front Room Audit preferred.
• Clear, persuasive communication to explain quality standards and influence stakeholders at all levels.
• Ability to develop and manage Quality Systems in compliance with regulatory bodies.
• Proficiency with Microsoft Office and PC SAS or similar analytics tools.

Responsibilities

• Develop and deliver a quality compliance strategy aligned with global standards.
• Oversee production unit's quality system activities: CAPA, change control, audits, and document control.
• Monitor local quality systems and report compliance health and audit results.
• Implement a cross-functional internal audit program meeting worldwide regulatory requirements.
• Represent the local quality system during regulatory and external inspections.
• Prepare and manage local regulatory and external audits, including post-audit activities.
• Drive QMS initiatives across the organization.
• Lead functional quality management to maintain scalable and compliant systems.
• Coordinate with other Quality Units to resolve compliance issues.
• Provide leadership and escalation of quality system issues across the organization.

Skills

Regulatory compliance

Quality systems

Audit leadership

FDA interactions

English communication

Team development

Quality management software

Education

Bachelor's degree in life sciences/engineering

Tools

Microsoft Office

PC SAS

Job description

Fresenius Kabi USA, LLC in Warrendale seeks a seasoned Quality Compliance Leader to shape and drive the global quality program for a distributed medical device portfolio. The role emphasizes strategic development of compliant quality systems and effective collaboration across units.

You will manage regulatory audits, monitor inspection readiness, and coordinate with global Quality Units to ensure ongoing regulatory compliance and robust quality performance.