Director Quality Management (m/w/d)

Bruker Corporation; Bremen, Bochum; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen im Bereich der analytischen Instrumentierung sucht einen Director Quality Management, um das Qualitätsmanagementsystem weiterzuentwickeln und sicherzustellen, dass die Produkte und Dienstleistungen höchsten Qualitäts- und Compliance-Standards entsprechen. In dieser Schlüsselrolle sind Sie für die Überwachung der Qualitätsabteilung verantwortlich und entwickeln Strategien zur Einhaltung von Vorschriften wie FDA QSR und ISO 13485. Sie arbeiten eng mit verschiedenen Abteilungen zusammen, um die Qualität und Effizienz der Prozesse zu gewährleisten. Wenn Sie eine Leidenschaft für Qualität und Compliance haben und in einem innovativen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• Erfahrung in der Leitung eines Qualitätsteams mit nachweislichen Erfolgen.
• Kenntnisse in FDA QSR, ISO 13485 und ISO 9001 erforderlich.

Aufgaben

• Überwachung der Qualitätsabteilung und Entwicklung von Qualitätsmanagementstrategien.
• Sicherstellung der Einhaltung externer Qualitätsanforderungen und interner Standards.

Kenntnisse

Qualitätsmanagement

FDA QSR

ISO 13485

ISO 9001

IVDR

Change Control

Corrective & Preventive Action (CAPA)

Statistik

Kommunikationsfähigkeiten

Ausbildung

Bachelor in Ingenieurwesen oder Naturwissenschaften

Tools

MS Office

SAP (S4/HANA)

MasterControl

Jobbeschreibung

Überblick

Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. As one of the world’s leading analytical instrumentation companies, Bruker develops high-performance scientific instruments and high-value analytical and diagnostic solutions that enable scientists to explore life and materials at molecular, cellular, and microscopic levels.

We have been driving innovation in analytical instrumentation for 60 years and today, Bruker continues to build upon its extensive range of products and solutions, its broad base of installed systems, and a strong reputation among its customers. Worldwide, more than 9,700 employees are working on this permanent challenge at over 100 locations on all continents.

The Director Quality Management is responsible for the evolution and improvement of the Quality Management System (QMS) necessary to ensure the highest quality, reliability, and regulatory compliance of products and services delivered. This applies to all activities of Bruker Daltonics GmbH & Co. KG, as well as the global distribution and support activities.

Aufgaben/Verantwortlichkeiten

• Direct supervision of all employees of the quality department in the Bruker Daltonics GmbH & Co. KG sites. Indirect supervision of all relevant personnel and activities in the organisation.
• Develop and implement quality management strategy and plans, including resources, systems, schedules, and budget, to support and integrate within the annual business plan and long-term strategy.
• Develop and maintain systems to meet external quality requirements relating to products and services. These requirements include: U.S. 21 CFR 820 (FDA QSR), ISO 9001, ISO 13485, IVDR, and MDSAP.
• Ensure efficient and effective compliance with these requirements in all parts of the organization, including research and development, production (in-house and outsourced), post-market surveillance, distribution and service/support.
• Support of production controls, and release of In Vitro Diagnostic and Research instruments, software and consumables according to appropriate regulations.
• Assure appropriate design controls for design changes and new product introduction according to appropriate regulations.
• Oversee the management of the Complaint, CAPA, Internal Audits, Supplier Quality and Post-Market Surveillance / Vigilance processes.
• Develop and maintain systems to measure performance against established goals and requirements.
• Monitor performance (in relevant areas) according to established goals and requirements and take necessary action to communicate/advise/assist according to performance levels.
• Monitor changes to external standards and regulatory requirements and integrate within internal quality management systems.
• Establish and implement necessary communication strategy for the improvement and awareness of quality and regulatory issues across all departments.
• Plan and manage departmental activities in accordance with agreed budgets and schedules.
• Report as necessary to senior management on changes in standards (internally and externally initiated) and on performance against standards.
• Coordinate with the quality management in other sites of the Bruker CALID Group as needed.

Qualifikationen

• Bachelor's degree in engineering or a specific scientific field, or demonstrably equivalent training and experience.
• Demonstrated, successful multi-year work experience in managing a quality team.
• Demonstrated, multi-year FDA QSR, ISO 13485, ISO 9001, and IVDR compliance responsibility and experience, as well as experience in managing a quality team.
• In-depth knowledge of design controls process, documentation management, change control, Corrective & Preventive action (CAPA), product complaints, MDR reporting, Nonconforming Product, and internal and supplier audits.
• Computer Skills: MS Office, SAP (S4/HANA preferred) and electronic quality management tools (e.g., MasterControl) to achieve the objectives.
• Certificates, Licenses, Registrations: Lead auditor certificate ISO 13485; ASQ Quality Engineer Certificate desirable.
• Other Skills and Abilities: Some background in statistics is essential. Six Sigma Green Belt or higher preferred. Proficiency in lean methodology and tools desirable. Excellent written and verbal communication skills across the entire organization.