Director (m/f/d) Product Lifecycle Management Quality – GMQS

Global Manufacturing, Quality & Supply (GMQS) is the operations division within Fresenius Medical Care, the world's leading provider of products and services for people with chronic kidney failure. Through its global network of more than 50 manufacturing sites and distribution centers, GMQS manages the procurement, production, distribution, and supply of renal and multi-organ therapy products. In about 150 countries, patients and customers depend on GMQS to manufacture and deliver a full range of products used in renal treatments as well as heart and lung therapies.

As Director (m/f/d) Product Lifecycle Management Quality you will serve as the Global Process Owner for Change Control and Product Lifecyle Management and will ensure that systems and process meet the requirements of the FDA.

  • Provide direction and governance over the implementation and execution of the established systems and tools to improve the Change Management and Product Lifecycle processes
  • Develop, improve and maintain a global document and Product Lifecycle Management (PLM) process, systems & tools
  • Establish full cross-referencing capability within document and Product Lifecycle Management tool against applicable regulations
  • Support local sites in the implementation of, and training in, the Change Management and Product Lifecyle Management systems
  • Establish the corporate global PLM Quality strategy for GMQS and Global Research & Development (GRD)
  • Conduct management reporting on the effectiveness of the Change Management and Product Lifecycle Management systems
  • Graduate university degree in natural sciences, business economics, business engineering or comparable course of study
  • Several years of leadership experience in a similar function within a regulated medical industry in the field of quality assurance
  • Advanced knowledge of applicable quality management standards (ISO13485, IS090010)
  • Solid understanding of Medical Device Regulations (MDR) 21 CFR Part 820, RDC ANVISA 16/2013, MHLWM0169, TG (MD) R Sch3, CMDR, MDD 93/42/EC, MDSAP program, EU Guidelines for GMP, ICH Q10
  • Profound knowledge of internal processes of the consolidated quality management system requirements
  • Strong people leadership competence with a collaborative management approach and the ability to motivate matrix teams
  • High language proficiency in English (written and spoken)
  • Willingness to travel domestically and internationally
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Projektmanagement / Medizintechnik / Qualitätsmanagement / Umwelt
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Medical Care
  • Standort:
  • Hessen / Bad Homburg
  • Bewerbungsfrist:
  • none - we look forward to your application

Ihre Benefits

  • 05_Langzeitkonto
Erfahren Sie mehr über unser Angebot
Yvonne Jakfeld
Fresenius Medical Care Deutschland GmbH
Bad Homburg
Ref. number: 42578

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

Director (m/f/d) Product Lifecycle Management Quality – GMQS

Global Manufacturing, Quality & Supply (GMQS) is the operations division within Fresenius Medical Care, the world's leading provider of products and services for people with chronic kidney failure. Through its global network of more than 50 manufacturing sites and distribution centers, GMQS manages the procurement, production, distribution, and supply of renal and multi-organ therapy products. In about 150 countries, patients and customers depend on GMQS to manufacture and deliver a full range of products used in renal treatments as well as heart and lung therapies.

As Director (m/f/d) Product Lifecycle Management Quality you will serve as the Global Process Owner for Change Control and Product Lifecyle Management and will ensure that systems and process meet the requirements of the FDA.

Your assignments

  • Provide direction and governance over the implementation and execution of the established systems and tools to improve the Change Management and Product Lifecycle processes
  • Develop, improve and maintain a global document and Product Lifecycle Management (PLM) process, systems & tools
  • Establish full cross-referencing capability within document and Product Lifecycle Management tool against applicable regulations
  • Support local sites in the implementation of, and training in, the Change Management and Product Lifecyle Management systems
  • Establish the corporate global PLM Quality strategy for GMQS and Global Research & Development (GRD)
  • Conduct management reporting on the effectiveness of the Change Management and Product Lifecycle Management systems

Your profile

  • Graduate university degree in natural sciences, business economics, business engineering or comparable course of study
  • Several years of leadership experience in a similar function within a regulated medical industry in the field of quality assurance
  • Advanced knowledge of applicable quality management standards (ISO13485, IS090010)
  • Solid understanding of Medical Device Regulations (MDR) 21 CFR Part 820, RDC ANVISA 16/2013, MHLWM0169, TG (MD) R Sch3, CMDR, MDD 93/42/EC, MDSAP program, EU Guidelines for GMP, ICH Q10
  • Profound knowledge of internal processes of the consolidated quality management system requirements
  • Strong people leadership competence with a collaborative management approach and the ability to motivate matrix teams
  • High language proficiency in English (written and spoken)
  • Willingness to travel domestically and internationally

Ihre Benefits

  • 05_Langzeitkonto
Erfahren Sie mehr über unser Angebot

Ihr Kontakt

Yvonne Jakfeld
Fresenius Medical Care Deutschland GmbH
Bad Homburg
Ref. number: 42578

Karrierelevel
Berufserfahrene
Einsatzbereich
Projektmanagement / Medizintechnik / Qualitätsmanagement / Umwelt
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Medical Care
Standort
Hessen / Bad Homburg
Bewerbungsfrist
none - we look forward to your application

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

Diese Jobs könnten Sie interessieren