Manager, Quality Systems

Fresenius Kabi USA•Warrendale, PA

6d•$115,000 - $130,000•Onsite

About The Position

This position is primarily 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.

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.
Experience dealing directly with FDA inspectors and other regulators during quality system audits.
Clear, persuasive communication essential for explaining quality standards, presenting data, and influencing stakeholders at all levels.
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.

Nice To Haves

Lead Auditor or ASQ professional certification highly desired (i.e. ISO 9001/13485 lead auditor, ASQ CQA, etc.).

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.