Director Quality Management (m/f/d)

in Heilbronn/Stolberg

Xenios AG - a company of the Fresenius Medical Care Group - is an innovative medical technology company focusing on heart and lung failure. The Novalung and Medos products offer a wide range of heart and lung support products via a single platform, the Xenios console.

Xenios mission is to improve patient well-being and care. The Novalung therapy aims at a paradigm shift in lung support: enabling the treatment of patients that are awake, self-determined and mobile.

Xenios AG has been part of Fresenius Medical Care, the world's leading provider of products and services for people with kidney disease since the end of 2016. Xenios complements the group's portfolio in the area of holistic multi-organ support of FME.

  • Direct and manage the Quality Management Department with 50 employees at Xenios AG
  • Consult local and regional top management on the realization and follow-up of management reviews to achieve product quality and business goals
  • Direct the continuing improvements for all functions within the Quality Systems Department
  • Participate in planning and implementing changes of the requirements for production and process control as well as the site’s associated documentation
  • Follow up of the implementation and of the assessment of effectiveness of corrective actions resulting from internal and corporate audits as well as from improvement projects
  • Establish relevant Quality Control functions to control and approve all produced medical devices and incoming materials in accordance with required specifications, legal and regulatory requirements
  • Cooperate with key stakeholders with the aim to develop and manage adequate environments in which to manufacture product to specification
  • Provide key Subject Matter Expert Support of Xenios Manufacturing activities and product line knowledge to support the organisations goal of standardisation, efficiency and continual improvement of product and process
  • Report to management about the management system performance

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  • Completed scientific, medical or technical education or equivalent
  • At least 5 years of experience in the production of health care products, especially in working with US FDA Class III devices
  • High engagement on achieving the objectives of the position
  • Good and professional relationship to and communication with superiors colleagues and subordinates to internal and external customers
  • Structured and team-oriented way of working
  • Good communication and presentation skills (fluent in German and English)
  • Willingness to travel domestically and internationally
  • Corporate benefits
  • Companies accident insurance
  • Free parking
  • Regular training and further education offers
  • Employer participation in your company pension scheme and your capital-forming benefits
  • Participation in various company events
  • Free drinks and fresh fruit
  • Vacation pay and much more

Please note that the Xenios AG benefits listed above differ from the Fresenius services.

We offer an unlimited full-time position in a modern work environment with great personal responsibility, personal development prospects and the opportunity to be part of medical innovations.

If you are looking for a future-oriented position in an international company, then we look forward to receiving your application via the career website of our parent company Fresenius Medical Care.

  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Entwicklung / Konstruktion / Medizintechnik / Sonstige / Qualitätsmanagement / Umwelt / Geschäftsleitung / Management
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Medical Care
  • Standort:
  • Baden-Württemberg, Nordrhein-Westfalen / Heilbronn, Stolberg
  • Bewerbungsfrist:
  • none - we look forward to your application
Natalia Schneider-Maier
Xenios AG
Human Resources
Ref. number: 35369

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 280.000 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 Quality Management (m/f/d)

in Heilbronn/Stolberg

Xenios AG - a company of the Fresenius Medical Care Group - is an innovative medical technology company focusing on heart and lung failure. The Novalung and Medos products offer a wide range of heart and lung support products via a single platform, the Xenios console.

Xenios mission is to improve patient well-being and care. The Novalung therapy aims at a paradigm shift in lung support: enabling the treatment of patients that are awake, self-determined and mobile.

Xenios AG has been part of Fresenius Medical Care, the world's leading provider of products and services for people with kidney disease since the end of 2016. Xenios complements the group's portfolio in the area of holistic multi-organ support of FME.

Your assignments / Your profile

  • Direct and manage the Quality Management Department with 50 employees at Xenios AG
  • Consult local and regional top management on the realization and follow-up of management reviews to achieve product quality and business goals
  • Direct the continuing improvements for all functions within the Quality Systems Department
  • Participate in planning and implementing changes of the requirements for production and process control as well as the site’s associated documentation
  • Follow up of the implementation and of the assessment of effectiveness of corrective actions resulting from internal and corporate audits as well as from improvement projects
  • Establish relevant Quality Control functions to control and approve all produced medical devices and incoming materials in accordance with required specifications, legal and regulatory requirements
  • Cooperate with key stakeholders with the aim to develop and manage adequate environments in which to manufacture product to specification
  • Provide key Subject Matter Expert Support of Xenios Manufacturing activities and product line knowledge to support the organisations goal of standardisation, efficiency and continual improvement of product and process
  • Report to management about the management system performance

-------------------------------------------------------------------------------------

  • Completed scientific, medical or technical education or equivalent
  • At least 5 years of experience in the production of health care products, especially in working with US FDA Class III devices
  • High engagement on achieving the objectives of the position
  • Good and professional relationship to and communication with superiors colleagues and subordinates to internal and external customers
  • Structured and team-oriented way of working
  • Good communication and presentation skills (fluent in German and English)
  • Willingness to travel domestically and internationally

Your benefits

  • Corporate benefits
  • Companies accident insurance
  • Free parking
  • Regular training and further education offers
  • Employer participation in your company pension scheme and your capital-forming benefits
  • Participation in various company events
  • Free drinks and fresh fruit
  • Vacation pay and much more

Please note that the Xenios AG benefits listed above differ from the Fresenius services.

We offer an unlimited full-time position in a modern work environment with great personal responsibility, personal development prospects and the opportunity to be part of medical innovations.

If you are looking for a future-oriented position in an international company, then we look forward to receiving your application via the career website of our parent company Fresenius Medical Care.

Ihr Kontakt

Natalia Schneider-Maier
Xenios AG
Human Resources
Ref. number: 35369

Karrierelevel
Berufserfahrene
Einsatzbereich
Entwicklung / Konstruktion / Medizintechnik / Sonstige / Qualitätsmanagement / Umwelt / Geschäftsleitung / Management
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Medical Care
Standort
Baden-Württemberg, Nordrhein-Westfalen / Heilbronn, Stolberg
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 280.000 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.

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