Quality Management Engineer, Supplier Auditor (m/f/d)

Getinge; München; Hybrid; EUR 45.000 - 80.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen erfahrenen Qualitätsmanagement-Ingenieur, der als Lieferantenauditor tätig wird. In dieser spannenden Rolle unterstützen Sie die Qualitätssicherung und arbeiten eng mit der F&E-Abteilung zusammen, um sicherzustellen, dass die Produkte den höchsten Standards entsprechen. Sie werden die Möglichkeit haben, Ihre Fähigkeiten in einem dynamischen Umfeld weiterzuentwickeln, während Sie an lebensrettenden Technologien arbeiten. Das Unternehmen bietet attraktive Arbeitsbedingungen, einschließlich flexibler Arbeitsmöglichkeiten und umfangreicher Weiterbildung. Wenn Sie leidenschaftlich an Qualitätssicherung interessiert sind, ist dies die perfekte Gelegenheit für Sie.

Leistungen

30 bezahlte Urlaubstage

Mobiles Arbeiten möglich

Moderne Arbeitsplatzgeräte

Business Bike

Karrieremöglichkeiten

Individuelle Schulungsprogramme

Qualifikationen

• Mindestens 3 Jahre Erfahrung im Qualitätsmanagement und Umweltmanagement.
• Erfahrung als Lead Auditor in Lieferantenaudits.

Aufgaben

• Verwalten des jährlichen Lieferantenauditplans.
• Durchführen von Lieferantenaudits als Lead Auditor.
• Unterstützen des CSV-Prozesses aus Qualitätsperspektive.

Kenntnisse

Qualitätsmanagement

Lieferantenaudits

ISO 13485

R&D Zusammenarbeit

CSV Prozesse

KPI Analyse

Interne Audits

Fließend in Englisch und Deutsch

Ausbildung

Studium in Medizintechnik, Ingenieurwesen oder Naturwissenschaften

Tools

QMS Dokumentation

Jobbeschreibung

With a passion for life

Join our diverse teams of passionate people and develop both personally and professionally. At Getinge, we aim to make life-saving technology accessible to more people and to make a real difference for our customers—to save more lives. We are looking for team players, forward thinkers, and game changers.

Are you seeking an inspiring career? You might have just found it.

We are currently hiring an Experienced Quality Management Engineer, Supplier Auditor to join our Quality department in Feldkirchen, Germany, part of the Critical Care product area at Getinge. This role involves supporting the organization as a Supplier Auditor, collaborating closely with our R&D department on projects, working on our CSV process, and continuously improving our quality management system.

Tasks & Responsibilities:

• Manage the annual supplier audit schedule
• Plan, prepare, and conduct supplier audits as Lead Auditor
• Participate in the selection, evaluation, monitoring, and development of suppliers
• Collaborate with suppliers on quality-related topics, including external audits
• Support the CSV process from a quality perspective
• Assist with Design Change Control and Design Control processes
• Perform internal audits (Internal Auditor)
• Prepare for and support external audits (notified bodies, authorities, customers)
• Contribute to process improvements and alignment with other Critical Care sites
• Report and analyze monthly KPIs
• Maintain, review, and approve QMS documentation and records
• Participate in internal quality projects

Required Profile:

• Degree in medical technology, engineering, science, or similar relevant education
• Minimum 3 years of hands-on experience in Quality and Environmental Management ISO 13485
• At least 2 years of experience as Lead Auditor in supplier audits
• Experience collaborating with R&D projects and CSV processes
• Knowledge of applicable standards and regulations
• Relevant training in QM / ISO 13485 / FDA / EU MDR
• Ideally trained as an Internal Auditor
• Experience in Quality/Environmental projects (e.g., CAPAs, EU MDR uplift) is advantageous
• Fluency in English and German, both written and spoken
• On-site work 1-2 days per week and willingness to travel (25%)

We Offer:

• High-quality products in a life-saving environment
• Attractive conditions, including 30 paid vacation days per year
• Possibility of mobile working
• Modern workplace equipment
• Business Bike and other benefits
• Career opportunities within a well-known company
• Individual training programs

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About Us

Getinge is committed to providing access to the best possible care for every person and community. We supply hospitals and life science institutions with products and solutions to improve clinical results and optimize workflows. Our offerings include products for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science. With over 12,000 employees worldwide, our products are sold in more than 135 countries.