Roche Diagnostics Automation Solutions (RDA) in the Stuttgart region is one of Roche's competence centers for the development and production of laboratory automation systems.
The Strategy, Governance and Project Team is responsible for the management of key quality projects and initiatives across the respective organization as well as for the representation of Quality Management ISS on global and local Quality and Regulatory strategic initiatives.
In your role as Senior Quality Manager (m/f/d), you work independently in different projects where you strive to meet Quality & Regulatory goals and objectives and improve processes continuously. You work in a matrix organization with Q&R colleagues in different locations.
This position is located in Kornwestheim. In 2021, RDA is concentrating the current three locations in the Stuttgart region at a permanent new site in Ludwigsburg.
Your responsibilities will include:
- You support, maintain and improve quality processes and ensure regulatory compliance
- You plan and prioritize resources in projects including the delegation of tasks as well as setting and keeping of deadlines
- You establish an efficient and effective communication process and information flow within the projects and you are accountable for the stakeholder management
- You are responsible for assuring and monitoring cGMP compliance (eg. FDA, IVDD, ISO) and the preparation of and participation in audits
- You conduct the training, coaching and mentoring of other quality managers or business partners in a professional manner to ensure that business needs are being met
- You review and author documents to support changes and you perform technical reviews
You bring the following qualifications:
- You completed your studies in Engineering, Medical devices or Science successfully (ideally Master diploma)
- You have at least five years of work experience in Quality Management, preferably Design Quality, and a strong background in project management
- You have been working in the medical device industry or in-vitro diagnostics for a minimum of at least 5 years with profound knowledge in a regulatory environment e.g. FDA QSR 820 and ISO 13485
- Your English skills are business fluent and your German is at least at B2 level
- You show exceptional analytical, conceptual and problem-solving abilities in combination with a high degree of communication- and team skills
We look forward to receiving your application!
Further information can be found at www.roche.de/about/standorte/waiblingen/index.html
We accept applications in German and English.
For a complete application, please add the following documents to your application in the step "Upload new Resume or CV":
A current curriculum vitae, a letter of motivation stating your desired salary (if available) and relevant certificates. Before sending your application, please note that no further documents can be added subsequently.