Quality and Compliance Manager
hace 2 semanas
About the Job
Fagron is a leading global company in personalized medical solutions, with a talented team of over 2,000 professionals in 34 countries. We serve over 200,000 customers worldwide, delivering innovative and high-quality solutions that enhance medical compliance and improve healthcare.
Job Mission
As a Quality and Compliance Manager, you will be responsible for managing and organizing our quality management system to ensure compliance with all regulations and continuously improve the quality of our services. You will ensure that our products and services meet the highest standards of quality and regulatory requirements in the regions where we operate.
Key Responsibilities
- Manage corporate quality management programs, including certification processes for ISO 14385
- Develop and drive continuous improvement to quality system processes through the development, execution, monitoring, and reporting of Quality Plans
- Undertake and manage regulatory inspections and audits, preparing and following up on audits to achieve continuous improvement of quality and processes
- Support the efficient and effective execution of the corrective action program, internal audit program, and other QMS subsystem elements, as well as support external audits and inspections
- Translate strategy into quality in actual projects, adhering to generally accepted quality standards, including GMP, GDP, etc.
- Act as a qualified person to release products and analyses, keeping up to date with national and international legislation and guidelines
- Develop and implement processes to receive approval for products and services, identifying compliance issues and conducting internal investigations
- Maintain regulatory documentation databases and ensure that all firm and regulatory policies and procedures are documented and communicated to employees
- Maintain good contact with authorities to anticipate changes or new developments and trends within the sector
About Fagron
Fagron is a trusted global company with a strong scientific core and a passion for innovation. We collaborate with partners to continuously improve and discover new solutions, bringing quality to customers and positively impacting people's lives.
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