Senior Manager Audits and Improvement IMS-EMEA (m/f/d)

61348 Bad Homburg
29.07.2020

Daten dieser Anzeige

Job-ID: 015737725
Senior Manager Audits and Improvement IMS-EMEA (m/f/d)

Fresenius Medical Care Deutschland GmbH

Germany

https://jobdb.softgarden.de/jobdb/public/jobposting/applyonline/click?jp=7284720

You will be mainly responsible for defining, documenting, implementing, maintaining and improving the IMS Audit and CAPA system. You will ensure that internal auditors are qualified and authorized within the scope of the IMS. You will act as an interface to the key functions of the IMS regarding Audits and CAPA. Furthermore, you will coordinate and monitor internal audit programs within in the IMS of EMEA region as well as resulting CAPA and you will perform internal audits personally. As an Expert in the Audit and CAPA system, you will evaluate and mitigate potential risks within the system's framework while keeping the processes and related computerized systems up-to-date and aligned with regulatory and operational requirements.

  / CAREER WITH A PURPOSE / Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care. freseniusmedicalcare.com Senior Manager Audits and Improvement IMS-EMEA (m/f/d) Within Fresenius Medical Care, the QREM Department (Quality, Regulatory Affairs & Management Systems) has the key responsibility to ensure that the company receives and maintains its marketing authorizations for Medical Devices and Drugs. For that purpose, an Integrated Management System (IMS) has been established to ensure compliance with applicable regulatory requirements.                                              ****************** As a Senior Manager Audits and Improvement IMS-EMEA (m/f/d), you will drive - in close corporation with relevant stakeholders - the processes and related computerized systems for carrying out internal audits and coordinating Third Party audits as well as execution of CAPA and Improvement projects in the context of the IMS of region EMEA (Europe, Middle-East and Africa). More Within Fresenius Medical Care, the QREM Department (Quality, Regulatory Affairs & Management Systems) has the key responsibility to ensure that the company receives and maintains its marketing authorizations for Medical Devices and Drugs. For that purpose, an Integrated Management System (IMS) has been established to ensure compliance with applicable regulatory requirements.                                              ****************** As a Senior Manager Audits and Improvement IMS-EMEA (m/f/d), you will drive - in close corporation with relevant stakeholders - the processes and related computerized systems for carrying out internal audits and coordinating Third Party audits as well as execution of CAPA and Improvement projects in the context of the IMS of region EMEA (Europe, Middle-East and Africa). Your assignments You will be mainly responsible for defining, documenting, implementing, maintaining and improving the IMS Audit and CAPA system. You will ensure that internal auditors are qualified and authorized within the scope of the IMS. You will act as an interface to the key functions of the IMS regarding Audits and CAPA. Furthermore, you will coordinate and monitor internal audit programs within in the IMS of EMEA region as well as resulting CAPA and you will perform internal audits personally. As an Expert in the Audit and CAPA system, you will evaluate and mitigate potential risks within the system's framework while keeping the processes and related computerized systems up-to-date and aligned with regulatory and operational requirements. Your profile You will have acquired a degree in scientific or technical studies or will have completed a comparable vocational training. You will have gained several years' working experience as an (Lead) Auditor or Quality Manager (ISO 13485, ISO 9001, ISO 14001, GxP), ideally in the MedTech or Pharma industry. You are characterized by excellent relationship building skills, the ability to adapt easily to work with a variety of people in various roles and levels of management in a complex organization. You would even be a better fit if you have a high level of IT affinity with deep knowledge of the lifecycle management of computerized systems in the regulated environment and enjoy using your English on a professional level. Please note that this position requires willingness to travel up to 10%. Zusätzliche Infos Are you ready to take your career to the next level? Well, in this role you will have the future opportunity to enhance your career and lead a small team of experts.                  We look forward to receiving your application. Apply now Send via email Print this page At a glance Career level: Professional Experienced Job category: Quality Management / Environment Working condition: Permanent / Full-time Business segment: Fresenius Medical Care Location: Bad Homburg / Hessen Closing date for applications: none - we look forward to your application Apply now Send via email Print this page Your contact Fresenius Medical Care Deutschland GmbH Bad Homburg Ref. number: 39578 About Fresenius Career with a purpose: Over 290,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com   One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons   The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits Your contact Fresenius Medical Care Deutschland GmbH Bad Homburg Ref. number: 39578 career.fmc-ag.com Career level: Professional Experienced Job category: Quality Management / Environment Working condition: Permanent / Full-time Business segment: Fresenius Medical Care Location: Bad Homburg / Hessen Closing date for applications: none - we look forward to your application About Fresenius Over 290,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Sonstige Branchen

Medizintechnik/ Optik

Gesundheits-/ Sozialwesen/ Medizin

Angestellter/ Fachkraft

Vollzeit

61348 Bad Homburg