Our Client, headquartered in Spain, has created an innovative portfolio of non-invasive lasers and cryoadipolisis devices for both clinics and med-spas. All products have been developed by the company’s in-house R&D team and are produced at the company’s own facility in Sofia, Bulgaria. The company has direct commercial operations in Europe, Latin America, Hong Kong and the US, and in addition manages a network of over 60 distributors.
200 employees around the world (Spain, Bulgaria, Italy, USA, Colombia, México, France, Hong Kong).
For the office in Sofia, we are looking for an experienced Plant QA Manager.
• Assuring that all manufactured products meet the applicable standards and regulations.
• Provide clear leadership for the development of an environment focused on Quality in the site.
• Main responsible for the Quality Management System.
• Ensuring that the Quality Policy and QMS procedures are effectively and efficiently deployed through the Organization.
• Scheduling and developing strategic quality project plans along with multidisciplinary teams to fit project deadlines.
• Maintenance and follow-up of the QMS and periodic effectiveness evaluation of it.
• Establish yearly plans for: audits, calibration and training programs (polyvalence matrix, backup of key positions, regular training for QMS, quality tools training and others).
• Train other departments and the quality team in all applicable aspects of the QMS and application of procedures.
• Lead the integration of the new QMS in the Bulgarian manufacturing site.
• Report to the QA&RA Director against agreed quality metrics (KPIs) on a monthly basis.
• Being responsible for the overall quality of products released by the company.
• Ensures the execution of corrective actions and compliance with customer’s specifications.
• Improving the Quality of Products and Services provided for the Organization by means of implementing systematic process for root cause analysis and PDCA process.
• Permanently review the status of the manufacturing License of the site in the Bulgarian Ministry of Health.
• SAP key user for the Quality Department.
• Prepare the annual Quality budget and forecasts and all Capital Expenditure proposals as well as ensuring compliance with legal standards.
• Degree in Engineering or other technical discipline.
• 5+ years of experience in Quality Assurance in the automotive industry. Experience in the Medical Devices industry is a clear advantage.
• 3+ years leading Quality Departments.
• Deep knowledge of ISO 9001 and IATF 16949. FDA regulations and ISO 13485 are a plus.
• Full expertise in use and deployment of quality tools (including but not limited to SPC, Gauge R&R, DoE, sampling plans, problem-solving methodologies and other modern Quality Tools).
• Strong statistical knowledge with advanced use of statistical software i.e. Minitab.
• Familiar with range of measuring and inspection equipment and able to interpret engineering drawings and specifications.
• Experience with SAP or other ERP system is a plus.
• High level of English.
• Analytical and deductive skills. Adaptability and open-minded. Excellent communication skills. Good trainer. Proactively contribute to creating a good team atmosphere.
To apply: please send your detailed CV. All candidates will be reviewed in strict confidentiality.