Senior Quality Assurance Manager

Role: Interim Site Quality Lead Contact: ahmedelemed.eu Contract length: 3-6 months Location: Hauts-de-France Do you want to participate in the quality of products that promote scientific discovery and contribute to improving the lives of patients? If so, we’re working with a global Medical Device manufacturer who is looking for an Interim Site Quality Lead. You will be responsible for managing a Quality Assurance team in the implementation and maintenance of an effective and integrated quality management system for production operations, research and development. Responsibilities: Develop and guide the quality team, ensuring effective implementation and maintenance of quality programs across various areas, including compliance and CAPA processes. Collaborate with site leadership and product managers to drive initiatives focused on enhancing product quality and improving the effectiveness of quality management systems. Ensure continuous compliance with regulatory standards and industry best practices, promoting adherence to Good Manufacturing Practices (GMP). Lead and coordinate all internal and external audits, including those conducted by regulatory bodies, customers, and other relevant organizations. Take part in quality process improvement projects, working closely with Quality Assurance teams to ensure consistency and optimization across processes. Foster strong communication and cooperation with Quality Assurance leaders at other sites to support the ongoing development and maintenance of a unified quality management system. Requirements: A minimum of 12 years of experience in Quality roles within the healthcare sector, with a strong background in industrial operations related to medical equipment manufacturing Demonstrated leadership skills with at least 5 years of experience managing and leading teams. Extensive experience in managing FDA inspections. Deep understanding of Quality Management Systems in the Medical Device/IVD field, along with a solid grasp of both national and international regulations (ISO 13485/17025, QSR, FDA, MDSAP, IVDD/R). Proven track record in handling quality project management. Fluent in English & French, capable of thriving in an international work environment. Highly committed, with the ability to meet deadlines and a strong focus on achieving results ✉️ If you are interested in this exciting role, please send your application directly to ahmedelemed.eu Would you like to find out more about our open opportunities? Visit https://www.elemed.eu/vacancies/ Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process. Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful. ___________________________________________________________________ Elemed is Europe’s leading MedTech technical recruiter. We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow. We won Best International Recruitment Agency at the Recruiter Awards 2021. At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices. ⚖️ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Location: Hauts-De-France, FR

Posted Date: 1/14/2025