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

Getinge; München; Sur place; EUR 65 000 - 95 000; Plein temps

Avantages offerts par ce poste

Wellness allowances

Generous family benefits

Joint company activities

Résumé du poste

Getinge is seeking a Quality Management Engineer (m/f/d) QMS and Compliance to strengthen our Quality department in Germany or Sweden. The role focuses on owning the internal audit process, coordinating CAPA activities, and advancing our quality management system within the Critical Care product area.

The candidate will support audits, drive QMS documentation, and lead quality-related projects while ensuring regulatory alignment across QM/ENV standards. Travel and on-site presence are required.

Qualifications

• Degree in medical technology, engineering, science or similar field.
• Minimum 3 years hands-on experience in Quality and Environmental Management, ISO 13485 environment.
• Knowledge of applicable standards/regulations in QM/ENV.
• Proven training in QM / ISO 13485 / FDA / EU MDR or similar.
• Ideally trained as Internal Auditor.
• Experience in QM/ENV-related projects (CAPA, EU MDR uplift) is a plus.
• Fluency in English; German or Swedish is advantageous.
• On-site presence 1–2 days per week and willingness to travel.

Responsabilités

• Own the internal audit process and plan the annual internal audit schedule.
• Conduct internal audits as internal auditor.
• Support external audits (notified bodies, authorities, customers).
• Support CAPA projects as CAPA coordinator.
• Collaborate on internal Quality projects (Management System Plan, CAPA).
• Contribute to process improvement and alignment with other sites.
• Report monthly KPIs.
• Maintain, review, and approve QMS documentation and records.

Connaissances

Quality & Environmental Mgmt

Auditing experience

Regulatory knowledge

English language

Formation

Degree in medical technology/engineering/science

Description du poste

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. 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.).

Tasks & Responsibilities

• Own the internal audit process, plan the annual internal audit schedule, follow-up of internal audit findings
• Conduct internal audits as 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 on process improvement and alignment with other Critical Care site
• 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 optimise 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.