Head of Quality Assurance (m/w/d)

61169 Friedberg (Hessen), 61169 Friedberg
02.08.2019

Daten dieser Anzeige

Job-ID: 010887302
Head of Quality Assurance (m/w/d)

Fresenius Kabi Deutschland GmbH

Germany

https://karriere.fresenius.de/de/job_application/4577994/apply

Functional and disciplinary Management of QA in Development and Production Unit at the local site Maintaining the local QM System according to the normative and legal requirements in conformance with Divisional QM and the local PU and Development Team. Safety Officer («Sicherheitsbeauftragter») for Medical Devcies according to § 30 section («Absatz») 2 «Medizinproduktegesetz» (MPG) and divisional Safety Officer QM Reporting on basis of Key Performance Indicators to Management and execution of Quality Assessments / Management Review. Activities of Quality Management Representative according to ISO 13485 ch. 5.5.2 und 21CFR820.20(3) Handling of potentially safety-related complaints Review and Approval of QM documents, change- and CAPA projects QM Training of employees

  / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. Head of Quality Assurance (m/w/d) Your assignments Functional and disciplinary Management of QA in Development and Production Unit at the local site Maintaining the local QM System according to the normative and legal requirements in conformance with Divisional QM and the local PU and Development Team. Safety Officer («Sicherheitsbeauftragter») for Medical Devices according to § 30 section («Absatz») 2 «Medizinproduktegesetz» (MPG) and divisional Safety Officer QM Reporting on basis of Key Performance Indicators to Management and execution of Quality Assessments / Management Review. Activities of Quality Management Representative according to ISO 13485 ch. 5.5.2 und 21CFR820.20(3) Handling of potentially safety-related complaints Review and Approval of QM documents, change- and CAPA projects QM Training of employees Your profile Completed degree in scientific or technical Studies Multiannual job experience in the Quality Assurance of Medical Devices or laboratory equipment Good knowledge of regulatory and national and international QM Systemrequirements for medical device manufacturer ( EU MDR, ISO 13485, 21 CFR820, Australian TG(MD)R, Health Canada CMDR, Japan MHLW Ordinance No. 169, Brazilian Good Manufacturing Practice) Very good knowledge about Medical Devices Proven work experience as a team leader Required knowledge regarding MPG - Safety Officer would be a plus Very good English and German language skills Strong oral and written communication skills Strong interpersonal and leadership skills Demonstrated ability to analyze and resolve problems Demonstrated ability to lead programs / projects Established project management skills Apply now Send via email Print this page At a glance Career level: Professional Experienced Job category: Quality Management / Environment Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Friedberg / Hessen Closing date for applications: none - we look forward to your application Apply now Send via email Print this page Your contact Judith Zimmermann Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 34129 About Fresenius Career with a purpose: Over 270,000 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 Judith Zimmermann Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 34129 fresenius-hemocare.de Career level: Professional Experienced Job category: Quality Management / Environment Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Friedberg / Hessen Closing date for applications: none - we look forward to your application About Fresenius Over 270,000 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

Technische Berufe/ Fertigung/ Produktion

Ingenieurwesen

Sonstige Branchen

Medizintechnik/ Optik

Bereichs-/ Abteilungs-/ Gruppenleitung

Angestellter/ Fachkraft

Vollzeit

61169 Friedberg (Hessen)

61169 Friedberg