Senior Quality Systems Leader – Medical Devices

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

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