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

Arbeitsagentur; München; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

Getinge seeks a Quality Management Engineer (m/f/d) QMS and Compliance to join our Quality department in Aschheim‑Dornach, Germany, or Solna, Sweden. You will own internal audit processes, coordinate CAPA, and support QA to maintain ISO 13485 compliance while driving quality improvements across sites.

The role emphasizes process improvement, KPI reporting, and cross‑functional collaboration with teams at different sites. On‑site presence 1–2 days weekly and some travel are required.

Qualifikationen

• Degree in medical technology, engineering or science or equivalent.
• Minimum 3 years of hands-on quality/environmental management, ISO 13485 experience.
• Knowledge of applicable standards and regulations (e.g., ISO 13485, FDA, EU MDR).
• Training in QM / ISO 13485 / FDA / EU MDR is preferred.
• Ideally trained as Internal Auditor.
• Experience in Quality- and Environmental-related projects (CAPA, EU MDR uplift).
• Fluent in English; Swedish or German is a plus.
• On-site presence 1–2 days per week; travel willingness required.

Aufgaben

• Own internal audit process and annual audit schedule; follow up on findings.
• Conduct internal audits as internal auditor.
• Support external audits by notified bodies, authorities and customers.
• Support CAPA projects as CAPA coordinator.
• Collaborate on internal quality projects and CAPA alignment.
• Contribute to process improvement and alignment across Critical Care sites.
• Prepare and report monthly KPIs.
• Maintain and approve QMS documentation and records as QA specialist.

Kenntnisse

Quality management

Internal auditing

CAPA coordination

Regulatory knowledge

Analytical skills

Team collaboration

Ausbildung

Science/Engineering degree

Jobbeschreibung

With a passion for life 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.

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.).

Tasks & Responsibilities

• 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

Desired Profile

• 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.

Why join Getinge

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.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science. Getinge employs over 12,000 people worldwide, and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Get to know us in our Company video.

PULSION Medical Systems SE | Human Resources | Hans‑Riedl‑Str. 21 | 85622 Feldkirchen [e-mail] | www.getinge.com/karriere

www.getinge.com