Medical engineer (m/w/d)

Arbeitsagentur; Hölzlhof; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Getinge is seeking a Quality Management Engineer (m/f/d) QMS and Compliance to reinforce the Quality department in Germany or Sweden. You will own internal audits, coordinate CAPA activities, and support external audits while driving continuous improvements to the QMS across sites.

Key duties include planning and executing audits, maintaining documentation, and reporting KPIs. English proficiency is required; German or Swedish language skills are a plus.

Qualifikationen

• Degree in medical technology, engineering, science, or a similar field.
• Minimum 3 years of hands-on quality and environmental management experience.
• Knowledge of applicable standards and regulations.
• Training in QM / ISO 13485 / FDA / EU MDR.
• Ideally trained as an Internal Auditor.
• Experience with quality- and environmental-related projects (CAPAs, EU MDR uplift) is a plus.
• Fluency in English; German or Swedish language skills are advantageous.
• On-site presence 1–2 days per week; willingness to travel.

Aufgaben

• Own the internal audit process and plan the annual internal audit schedule.
• Conduct internal audits as an internal auditor.
• Support external audits by notified bodies, authorities, and customers.
• Support CAPA projects as CAPA coordinator.
• Collaborate on internal quality projects (MSP, CAPA) and drive improvements.
• Report monthly KPIs and maintain QMS documentation and records.

Kenntnisse

Internal Auditor

Quality audits

CAPA coordination

Regulatory knowledge

ISO 13485

English fluency

Travel willingness

Ausbildung

Degree in medical technology, engineering, science, or similar field

Jobbeschreibung

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers-and to save more lives, we need team players, forward thinkers, and game changers.

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

Be part of Getinge as a

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

We are currently looking for an experienced Quality Management Engineer (m/f/d) QMS and Compliance to join our Quality department in Aschheim-Dornach, Germany, or Solna, Sweden, part of the Critical Care product area at Getinge. This role will support the organization as the internal audit process owner, CAPA coordinator, and QA specialist, while continuously improving our quality management system and supporting quality-related projects (e.g., implementation of new tools, CAPA, etc.).

• Own the internal audit process, plan the annual internal audit schedule, and follow up on internal audit findings
• Conduct internal audits as an internal auditor
• Support of external audits (notified bodies, authorities, customers)
• Support of CAPA projects as CAPA coordinator
• Collaboration in and owning internal Quality projects (management system plan, CAPA)
• Continuous contribution to process improvement and alignment with other Critical Care sites
• Provision and reporting of monthly KPIs
• Maintenance, review and approval of QMS-related documentation and records as QA specialist

• Degree in medical technology, engineering, science, or a similar relevant field
• Minimum 3 years of hands-on experience in quality and environmental management, ideally in an ISO 13485 environment
• Relevant knowledge of the implementation and application of applicable standards and regulations
• Proven external and/or internal training in QM / ISO 13485 / FDA / EU MDR
• Ideally trained as an Internal Auditor
• Demonstrated experience in Quality- and Environmental-related projects (e.g., CAPAs, EU MDR uplift) is an advantage
• Fluency in written and spoken English; Swedish or German (depending on the location) is an advantage
• On-site presence of at least 1-2 days per week is expected; willingness to travel is required

In addition to your technical expertise, we highly value your personality. We believe you are a result-oriented and collaborative team player who takes ownership of your work and can operate independently when needed. You have strong analytical skills, a pragmatic mindset, and the ability to build relationships with stakeholders across different functions, seniority levels, and cultures. You thrive in a changing environment and approach challenges with professionalism and diplomacy.

We think you have an ambition for continuous development and a strong interest in staying up to date with the latest trends, regulations, and best practices within Quality Management, Medical Devices, and Supplier Quality.

At Getinge, we see ourselves as Team Players, Forward Thinkers, and Game Changers. We value proactive individuals who contribute to continuous improvement and organizational development.

We offer a competitive compensation and benefits package, including wellness allowances, generous family benefits, and joint company activities. Everything to ensure we support your well-being and goals.

Most importantly, this is a role where you can truly make a difference by contributing to the quality and safety of life-saving medical devices while helping shape the future of quality and compliance within Getinge.