Medical global process owner audits

The Global Process Owner Audits will identify and drive improvement in the audit process and auditing competences, while ensuring compliance to relevant requirements (e.g., ISO 13485, EU MDR, EU IVDR, MDSAP). This role emphasizes the implementation of digital tools and data analytics to enhance auditing knowledge, audit reporting accuracy, efficiency, and real-time monitoring. The Global Process Owner will work cross-functionally and globally to foster a culture of compliance, data-driven insights, and process optimization within the organization. Responsibilities Ensuring Global Compliance: Stay up to date with the latest regulatory requirements and ensure our audits adhere to required standards and guidelines. Improvement: Use data analytics to evaluate process performance, generate meaningful dashboards for stakeholders and identify and implement improvements, applying state of the art structured approaches. Developing and Maintaining Knowledge: Develop training for the next generation of auditors, and ensure existing auditors maintain their knowledge of medical device certification. Operational support: Provide guidance to auditors, solve deviations and handle escalations professionally. Driving Innovation and digitalization: Identify and implement improvements to our audit processes, streamlining efficiency and enhancing effectiveness, making it easy to learn and put into practice. Identify and drive initiatives to implement audit trail management, real-time data access, and automated reporting. Collaborating Across Borders: Work with a diverse team of experts and stakeholders (auditors, quality managers and other process owners) from around the world, sharing knowledge and fostering innovation. What we expect from you A bachelor or university level degree or higher in a scientific field (e.g., biomedical engineering, electrical engineering, or life sciences etc.); At least 5 years of experience in medical device auditing or audit management; A deep understanding of quality management systems and regulatory requirements (e.g., EU MDR, EU IVDR, ISO 13485, MDSAP, ISO 17021-1) and experience in implementing these requirements; Process thinker with demonstrated ability to analyze complex processes, identify areas for improvement, and implement effective solutions; Practical, result driven and detail-oriented while maintaining a helicopter view of the overall goals and QMS structures; Strong organizational and time-management skills, with the ability to manage multiple priorities and deadlines; Proficiency in digitalization and data analytics; Excellent English communication and interpersonal skills, both written and verbal, with a track record of effective collaboration across departments. What's in it for you You will be given every opportunity to further develop the Medical global audit process approach. You work and collaborate closely together with experts worldwide in a collaborative work environment where your contributions are valued. Our employees are our face and driving force. We offer an attractive salary and a good benefits package. We consider it important to give room for growth and development. The position can be based in the Netherlands or executed remotely with occasional travel to the Netherlands. About us DEKRA is one of the world’s leading testing, inspection, and certification (TIC) companies offering innovative professional services in the fields of vehicle inspection, expert appraisals, industrial product testing & certification, management system certifications, leadership consulting, and much more. DEKRA is a purpose-driven organization with a deep passion to make the world a safer place on the road, at work and home. At DEKRA, you will be part of a growing organization with a near 100-year history employing over 45,000 employees in more than 60 countries around the globe. Leading complex regulatory and technical projects, DEKRA is a global supplier of certification of medical devices. We are one of the five largest certification bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostics. As an established, well-recognized certification body, we maintain a global network of offices, taking pride in helping our client’s gain worldwide access to markets including Europe, UK, Taiwan, Singapore, the USA, Canada, Brazil, Australia, and Japan. As Medical Device Notified Body, Certification Body and Auditing Organization, the compliance, efficiency and effectiveness of our processes are at the core of our business. Therefore, it is imperative that our processes and approaches excel. In order to strengthen these capabilities, we are looking for a Global Medical Process Owner Audits. #J-18808-Ljbffr