Quality Management Engineer (m / w / d) QMS and Compliance

Getinge; München; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Getinge is seeking a Quality Management Engineer in Munich to oversee supplier audits, enhance the quality management system, and ensure compliance with ISO 13485 standards. This role involves collaboration with R&D and requires a degree in a relevant field, alongside significant experience in quality management and auditing.

Leistungen

30 paid vacation days per year

Possibility for mobile working

Business Bike and corporate benefits

Personalized training programs

Qualifikationen

• At least 3 years of experience in Quality Management ISO 13485.
• Minimum 2 years as Lead Auditor in supplier audits.
• Fluent in English and German.

Aufgaben

• Manage the annual supplier audit schedule.
• Support the CSV process from a quality perspective.
• Perform internal audits as Internal Auditor.

Kenntnisse

Quality Management

Auditing

Process Improvement

Supplier Collaboration

Ausbildung

Degree in medical technology, engineering, or science

Jobbeschreibung

Join our diverse teams of passionate people and build a career that fosters personal and professional growth. At Getinge, our mission is to make life-saving technology accessible to more people. To truly make a difference for our customers and save lives, we seek team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

We are currently seeking an experienced Quality Management Engineer (m/w/d) QMS and Compliance to join our Quality department in Feldkirchen, Germany. This role, within the Critical Care product area, will support the organization as a Supplier Auditor, collaborate closely with our R&D department on projects, work on our CSV process, and continuously improve 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 as Internal Auditor
• Prepare and support external audits (notified bodies, authorities, customers)
• Contribute to process improvement and alignment across Critical Care sites
• Provide and report on monthly KPIs
• Maintain, review, and approve QMS-related documentation and records
• Participate in internal quality projects

Required Profile:

• Degree in medical technology, engineering, science, or a similar relevant field
• At least 3 years of hands-on experience in Quality and Environmental Management ISO 13485
• Minimum 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
• Training as an Internal Auditor is a plus
• Experience in Quality / Environmental projects (e.g., CAPAs, EU MDR updates) is advantageous
• Fluent in English and German, both written and spoken

On-site work 1-2 days per week; willingness to travel (up to 25%)

We offer:

• High-quality products in a life-saving environment
• Attractive conditions, including 30 paid vacation days per year
• Possibility for mobile working
• Business Bike and corporate benefits
• Career advancement opportunities in a renowned company
• Personalized training programs

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 outcomes and optimize workflows. Our offerings include products for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life sciences. With over 12,000 employees worldwide, our products are available in more than 135 countries.