Senior Quality Systems Manager, Medical Devices Compliance

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

Job summary

Fresenius Kabi in Warrendale, PA, seeks a Manager, Quality Systems to provide compliance oversight for local quality systems in a medical device production unit. Responsible for reporting on regulatory compliance health and partnering with functional managers to maintain scalable, compliant systems.

The role represents local quality during global initiatives and audits; leads internal audit programs; drives QMS improvements and collaborates across quality units.

Qualifications

• Bachelor’s degree in life science, engineering or related discipline.
• 8–10 years of experience with regulatory environment for medical devices (global). Knowledge of 21 CFR Part 11, 820, ISO 13485, ISO 14971.
• Lead Auditor or ASQ certification highly desired (ISO 9001/13485 lead auditor, ASQ CQA).
• Experience with FDA inspections and quality system audits.
• Strong English communication skills and ability to influence stakeholders at all levels.

Responsibilities

• Develops and delivers quality compliance strategy aligned with global quality, regulatory standards and production unit requirements.
• Oversees quality system activities: CAPA, change control, document control, internal audits, investigations and controls.
• Monitors local quality system performance and reports on compliance health, inspection readiness, and audit results.
• Implements cross-functional internal audit programs to ensure regulatory and global quality system requirements are met.
• Represents local quality system during regulatory inspections and manages local audits.

Skills

Front Room Audit

Regulatory knowledge

Quality Management Systems

Communication

Audit reporting

MS Office / PC SAS

Education

Bachelor's degree in life science/engineering

Tools

Microsoft Office

PC SAS

Job description

Fresenius Kabi in Warrendale, PA, seeks a Manager, Quality Systems to provide compliance oversight for local quality systems in a medical device production unit. Responsible for reporting on regulatory compliance health and partnering with functional managers to maintain scalable, compliant systems.

The role represents local quality during global initiatives and audits; leads internal audit programs; drives QMS improvements and collaborates across quality units.