Senior Quality Systems Leader – Medical Devices & Compliance

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

Benefits offered by this job

Annual Target Bonus

Medical, dental, vision coverage

401(k) with company contribution

Job summary

Fresenius Kabi USA seeks a Manager, Quality Systems to oversee local quality systems compliance for the Warrendale production unit and to report on regulatory health. The role partners with functional managers to develop scalable, compliant systems and represents the local system in global initiatives and audits.

The position requires 8–10 years of medical device regulatory experience, strong audit skills, and lead auditor/ASQ certifications.

Qualifications

• Bachelor's degree required in a life science, engineering, physical science or related discipline.
• 8–10 years of experience with regulatory environment for medical devices (21 CFR Parts 11, 820; ISO 13485; ISO 14971).
• Lead Auditor or ASQ certification highly desirable (ISO 9001/13485).
• Experience dealing with FDA inspectors during quality system audits. Front Room Audit experience preferred.

Responsibilities

• Develops and delivers quality compliance strategy aligned with global quality and regulatory requirements.
• Executes and improves the production unit’s quality system activities (CAPA, controls, investigations, audits, change control, document control).
• Monitors local quality systems and reports on compliance health and audit results.
• Implements cross-functional internal audit program to meet worldwide regulatory requirements.
• Represents local quality system during regulatory and external inspections.

Skills

Leadership

Communication

Auditing

Regulatory knowledge

Team development

Analytical skills (Office/SAS)

Education

Bachelor's degree in life science/engineering/physical science

Tools

Microsoft Office

SAS

Job description

Fresenius Kabi USA seeks a Manager, Quality Systems to oversee local quality systems compliance for the Warrendale production unit and to report on regulatory health. The role partners with functional managers to develop scalable, compliant systems and represents the local system in global initiatives and audits.

The position requires 8–10 years of medical device regulatory experience, strong audit skills, and lead auditor/ASQ certifications.