Quality Systems Manager

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

The Manager, Quality Systems is responsible for providing compliance oversight for local quality systems compliance and procedures for the Fresenius Kabi medical device production unit in Warrendale, PA. The position is responsible for reporting on the health of regulatory compliance and partnering with functional managers to develop and maintain scalable, compliant systems. In addition, the Manager, Quality Systems will represent the local quality system in global and divisional initiatives expected to impact the local quality system and host and facilitate effective third‑party audits.

Responsibilities

• Develops and delivers quality compliance strategy in alignment with global quality, divisional, production unit, and local and international regulations and standards.
• Directly responsible for ongoing execution and improvements to the production unit’s quality system activities, which includes, but not limited to: Corrective & Preventative Action, management controls, , complaint investigations, internal auditing, change control, and document control.
• Monitors the performance of local quality systems and report to management periodically on compliance health, inspection readiness, and audit results.
• Develops and implements a cross‑functional internal audit program to ensure that all worldwide regulatory and global quality system requirements are implemented and met at the production unit.
• Represents the local quality system during regulatory and external inspections.
• Prepares and manages local regulatory and external audits, including post‑audit activities.
• Drives QMS initiatives throughout the organization.
• Partners with and leads functional quality management to develop and maintain high performing, scalable and compliant quality systems.
• Interacts with other Quality Units within Fresenius- Kabi Devices Division for resolution to compliance issues.
• Provides leadership and guidance for effective and timely communication and appropriate escalation of quality system issues to all levels of the organization.

Please note: This position cannot provide employment‑based immigration sponsorship now or in the future. Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires.

Requirements

• 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 for globally distributed products: 21 CFR Parts 11, 820, ISO 13485, ISO 14971,Quality systems expert with knowledge of QSR, ISO, MDD, CMDR, MDSAP and MEDDEV requirements. Ability to develop and manage Quality Systems in compliance with all applicable regulatory bodies.
• Lead Auditor or ASQ professional certification highly desired (i.e. ISO 9001/13485 lead auditor, ASQ CQA, etc.).
• Experience dealing directly with FDA inspectors and other regulators during quality system audits. Front Room Audit Experience preferred.
• Communication and Influence: Clear, persuasive communication essential for explaining quality standards, presenting data, and influencing stakeholders at all levels.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
• Team Development and Coaching: Effectively hires, develops, coaches, manages and motivates staff. Writes and administers performance appraisals.
• Proven ability to use computer software and applications, including intermediate/advanced functions Microsoft Office (Word, Excel, PowerPoint and Access) and/or PC SAS or other analytical software packages, to share, retrieve, research and present business information.

Additional Information

Salary Range: $115,000 to $130,000 Yearly + 10% Annual Target Bonus

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.