Manager, Quality Systems

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

Job Summary

Salary Range: $115,000 to $130,000 Yearly + 10% Annual Target Bonus This position is primary 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 guideance for effective and timely communication and appropriate escalation of quality system issues to all levels of the organization.

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.
• 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.
• 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.

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.

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.

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, and wellness program.

• medical coverage
• dental coverage
• vision coverage
• life insurance
• disability
• 401K with company contribution
• 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.

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.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life.

Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.