Project Manager eQMS (m/f/d)

Our Offer:

• You will receive fair and reliable compensation based on the GVP/DGB collective agreement. Depending on the industry of assignment, attractive bonuses may apply.
• We offer you a professional working environment with clear structures and good development prospects.
• From the very beginning, we will support you personally and advise you individually on all questions regarding your assignment.
• With our employee program Orizon PlusPunkte, you will benefit from numerous extras. These include, for example, health offers, shopping discounts, or support in special life situations.
• We offer you a company pension scheme so that you are well-secured for the future.
• Your recreational leave is up to 30 days per year – so that you can recharge your batteries.

Your future workplace: We are looking for you as a Project Manager eQMS (m/f/d) in Aalen at the earliest possible date.

Your tasks:

• Development of the overall concept for the digitalization of the Quality Management System (QMS), taking into account organizational development and the integration of various QMS systems within the organization.
• Creation of project and quality plans for the electronic Quality Management System (eQMS).
• Leading projects for the selection and implementation of the eQMS.
• Reporting to the steering committee on project progress regarding budgets, resources, and schedule.
• Determination of user requirements for an eQMS tool.
• Conducting market research and evaluating the eQMS tool based on user requirements, efficiency, costs, and reference user ratings.
• Ensuring that the solution provided by the software vendor meets the predefined requirements.
• Defining the necessary implementation activities, the scope of outsourcing to the software vendor, and the acceptance criteria.
• Planning the necessary CSV activities
• Enabling data-driven decision-making
• Creation of training materials and conducting basic training for user groups
• Compilation of comprehensive process documentation for the transfer of the eQMS tool from the project into the line organization
• Ensuring compliance with applicable standards and regulatory requirements, such as ISO 13485:2016, 21 CFR Part 11, GAMP5, GxP, MDSAP, and EU MDR
• Establishing effective cooperation with corporate IT to ensure optimal integration into the IT infrastructure (interface management).

Your profile:

• You possess a Master's degree in data management, engineering, or a comparable qualification.
• Alternatively, you have successfully completed studies in business informatics, computer science, industrial engineering, business administration, or a comparable course of study.
• You have at least 10 years of experience and an affinity for the implementation and application of QMS software systems in the medical technology industry. Additional experience in the pharmaceutical industry is an advantage.
• You have already successfully led a large, cross-functional project in the field of QMS, ideally also in connection with a software implementation.
• Knowledge of supporting software solutions for QMS purposes, such as Veeva Vault, Babtec.Q, Trackwise, and Polarion, is required.
• Knowledge of guidelines, standards, and regulations for medical devices, such as ISO 13485, ISO 9001, EU-MDR, MDSAP, 21 CFR Part 11, and GAMP5
• Knowledge and skills in project management
• High customer orientation
• Knowledge in the design and optimization of processes
• A personality characterized by a positive attitude toward change, questioning existing processes, and openness to innovative solutions.
• A confident appearance as well as teamwork, communication, and moderation skills.
• Very good knowledge of interface management.
• High ability for independent, consistent, structured, and solution-oriented work as well as strong conceptual skills.
• High motivation, willingness to take on responsibility, and enjoyment in familiarizing yourself with new topics.
• Very good English skills in speaking and writing. German skills are an advantage.
• Willingness to travel.

Your partner: With over 50 locations, the Orizon Group is one of the leading personnel service providers in Germany and part of the international BREXA Holdings Inc. group. We offer personnel solutions ranging from classic temporary employment to specialized recruiting and outsourcing services. Our subsidiaries OTTO Work Force Deutschland GmbH and jobs in time medical GmbH complement the portfolio with a focus on EU recruiting and medical professionals, respectively.

Application and inquiries: We look forward to receiving your applications (stating availability and salary expectations) via email to bewerbung.ostwuerttemberg@orizon.de or via our application module on this page. For questions, Ms. Rukwid is available at the telephone number +49 7321 93450. The salary stated here may not necessarily include all components (e.g., industry bonuses, Christmas bonuses, shift bonuses, etc.). The binding salary is to be clarified in a personal interview. Further information can be found at orizon.de We take the protection of your personal data seriously: www.orizon.de/de/datenschutzvereinbarungen