Manager, Quality Systems

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

Job Summary

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

Responsibilities

1. Develops and delivers quality compliance strategy in alignment with global quality, divisional, production unit, and local and international regulations and standards.

2. 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.

3. Monitors the performance of local quality systems and report to management periodically on compliance health, inspection readiness, and audit results.

4. 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.

5. Represents the local quality system during regulatory and external inspections.

6. Prepares and manages local regulatory and external audits, including post-audit activities.

7. Drives QMS initiatives throughout the organization.

8. Partners with and leads functional quality management to develop and maintain high performing, scalable and compliant quality systems.

9. Interacts with other Quality Units within Fresenius- Kabi Devices Division for resolution to compliance issues.

10. Provides leadership and guideance 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 expire s.

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

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

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, 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.