We currently have an opportunity for a Quality Systems Manager to provide compliance oversight for local quality systems compliance and procedures for our medical device production unit in Warrendale, PA.
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, production and process 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.
Fresenius Kabi offers an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match.
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, disabilities, or protected veteran status.
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 and MEDDEV requirements. Ability to develop and manage Quality Systems in compliance with all applicable regulatory bodies.
Lead Auditor or ASQ professional certification (i.e. ISO 9001/13485 lead auditor, ASQ CQA, etc.).
Experience dealing directly with FDA inspectors and other regulators during quality system audits.
Excellent interpersonal skills with strong written and oral communication skills.
Demonstrated strong analytical and problem-solving skills.
Ability to lead, coach, develop, and manage performance of employees.
Good project management skills.
Microsoft Office (Word, Excel, PowerPoint and Access) and/or PC SAS or other analytical software packages, to share, retrieve, research and present business information.
Internal Number: WAR00071
About Fresenius Kabi
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical 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. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.