Manager, Quality Systems

RXinsider LTD.; Warrendale (Allegheny County); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi is seeking a Manager, Quality Systems in Warrendale, PA to lead regulatory compliance and govern the local quality system in alignment with global standards. The role involves driving corrective actions, internal audits, and cross-functional improvements to ensure inspection readiness and robust quality programs.

The ideal candidate will have 8–10 years of medical device regulatory experience, lead/audit certification, and strong communication skills to engage with regulators and

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 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.
• 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.
• 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.
• Team Development and Coaching: Effectively hires, develops, coaches, manages and motivates staff.
• 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.

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: 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.

Skills

Communication skills

Team development

Regulatory/audit experience

English proficiency

Education

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

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

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 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.