Senior Quality Manager (m/w/d) Group Certification & Audits MD & IVD

As a leading company in the field of software solutions for healthcare, we operate in 19 countries and employ over 9,000 dedicated employees. You will work in a dynamic and innovative environment that is full of opportunities. With your commitment and passion, you have the opportunity to make a sustainable difference. Together we shape the health system of the future. Be part of our mission and make the difference – for a world where knowledge saves life! As Senior Quality Manager (m/w/d), you will be critical in the development, implementation and implementation of an international, group-wide certification strategy and the approval of products. You make sure that our certification approach is consistent, cost-effective and adapted to the individual needs of the organizational units. To do this, you will bring a deep understanding of the current and upcoming regulatory requirements, the associated standards and experience in building integrated management systems and complex certification programs in a large, diverse and globally represented organization. You work closely with numerous internal stakeholders and external certification service providers that appreciate your well-founded knowledge of software development, IT processes and the creation of the required technical documentation.

Your post: Design and implement a tailor-made, optimized certification approach for the relevant organizational units of our group. Analyze existing certifications of our organisations to implement necessary standard extensions efficiently and scalable. Develop and implement structured processes to effectively control the certification status within the group. Lead certification projects with a clear focus on the successful implementation – from the first concept to the conclusion and thus provide for a consistent readiness to test, which is appreciated and supported by employees in daily operation. Maintaining and deepening strong relationships with different stakeholders to ensure harmonious cooperation and to optimise and successfully shape the preparation and implementation of internal and external audits. That's what you bring: Multiannual professional experience in quality management, certifications and/or audit, in the service environment or by MDs or IVDs already placed on the market Successful degree in a relevant field, e.g. quality management, engineering or similar In-depth knowledge in ISO/IEC/EN standards 9001, 13485, 14971, 62304 and in the regulatory field of MDR and IVDR and expert knowledge in process documentation and improvement Very good knowledge of German and English Excellent communication skills, proactive operation, leadership experience in cross-functional teams and the ability to shape training for stakeholders You can expect from us: Mobile Work: Work flexibly on two days per week remote and on 3 days on site Feel-good management: We offer fresh food every day with a varied selection of dishes Health: Use the Koblenz gym and visit our free sports courses. Childcare: Our in-house kindergarten on Koblenzer Campus allows you to work more flexibly Events: Take part in internal events and activities, these take place regularly on site but also remotely.

Nice is part of CGM! We look forward to your application regardless of disability, gender, nationality, ethnic and social origin, religion, age and sexual orientation and identity.

Convinced? Apply now online with your meaningful application documents (including your certificate, salary presentation and the next possible entry date).

As a leading company in the field of software solutions for healthcare, we operate in 19 countries and employ over 9,000 dedicated employees. You will work in a dynamic and innovative environment that is full of opportunities. With your commitment and passion, you have the opportunity to make a sustainable difference. Together we shape the health system of the future. Be part of our mission and make the difference – for a world where knowledge saves life! As Senior Quality Manager (m/w/d), you will be critical in the development, implementation and implementation of an international, group-wide certification strategy and the approval of products. You make sure that our certification approach is consistent, cost-effective and adapted to the individual needs of the organizational units. To do this, you will bring a deep understanding of the current and upcoming regulatory requirements, the associated standards and experience in building integrated management systems and complex certification programs in a large, diverse and globally represented organization. You work closely with numerous internal stakeholders and external certification service providers that appreciate your well-founded knowledge of software development, IT processes and the creation of the required technical documentation.

Your post: Design and implement a tailor-made, optimized certification approach for the relevant organizational units of our group. Analyze existing certifications of our organisations to implement necessary standard extensions efficiently and scalable. Develop and implement structured processes to effectively control the certification status within the group. Lead certification projects with a clear focus on the successful implementation – from the first concept to the conclusion and thus provide for a consistent readiness to test, which is appreciated and supported by employees in daily operation. Maintaining and deepening strong relationships with different stakeholders to ensure harmonious cooperation and to optimise and successfully shape the preparation and implementation of internal and external audits. That's what you bring: Multiannual professional experience in quality management, certifications and/or audit, in the service environment or by MDs or IVDs already placed on the market Successful degree in a relevant field, e.g. quality management, engineering or similar In-depth knowledge in ISO/IEC/EN standards 9001, 13485, 14971, 62304 and in the regulatory field of MDR and IVDR and expert knowledge in process documentation and improvement Very good knowledge of German and English Excellent communication skills, proactive operation, leadership experience in cross-functional teams and the ability to shape training for stakeholders You can expect from us: Mobile Work: Work flexibly on two days per week remote and on 3 days on site Feel-good management: We offer fresh food every day with a varied selection of dishes Health: Use the Koblenz gym and visit our free sports courses. Childcare: Our in-house kindergarten on Koblenzer Campus allows you to work more flexibly Events: Take part in internal events and activities, these take place regularly on site but also remotely.

Nice is part of CGM! We look forward to your application regardless of disability, gender, nationality, ethnic and social origin, religion, age and sexual orientation and identity.

Convinced? Apply now online with your meaningful application documents (including your certificate, salary presentation and the next possible entry date). JOBV1_EN