.Experiência mínimo de 5 años en posición gerencial en industria medica- Experiência mínima de 5 años en posición gerencial en industria médica.- Experto en ISO 9001/13485.- Ingles Fluido.- Fuerte Liderazgo.- Visión de Negocios.- **SUMMARY**:_- **Responsible for directing, planning, organizing and controlling the processes, procedures, policies and activities for the assurance of the quality of the products according to the guidelines established by the clients and in compliance with the ISO 9001: 2015 and ISO 13485, reporting to Plant Manager.**_- **All job responsibilities must be performed in accordance with the Company's Principles of Ethical Business Conduct.**_- **ESSENTIAL DUTIES AND RESPONSIBILITIES**:_- **Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards.**_- **Improve efficiency for waste reduction, customer complaints, etc. Including always the continuous improvement.**_3. _**Supervise the preparation, updating in the system of quality documentation, basing the processes on the standard of ISO 9001: 2015 and ISO 13485.**_- **Maintain daily communication with the Departments to follow the established processes and together take actions for the improvement or problems solution detected in the product or in the processes.**_- **Responsible to follow up and ensure that the personnel of the Department under her responsability have the proper training to performance the job duties.**_6. _**Regulatory ensure manufactured products are appropriately licensed, produced and marketed.**_7. _**Regulatory are every stage in a product's life span; from conducting and devising products trials, to getting licenses for the product and ensuring it meets regulations, to actually writing the product labels and accompanying information leaflets.**_**QUALIFICATIONS**:_- **To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The requirements listed below are representative of the knowledge, skill, and/or ability required. Needs scientific, legal and business knowledge to scrutinizing scientific and legal documents.**_- **EDUCATION and/ or EXPERIENCE**:_- _**Excellent oral and written communication skills in both English and Spanish.**_- **Bachelor's Degree in a Technical or one of the Life Sciences field.**- **Five years or more of experience in equivalent role.**- **Strong knowledge in ISO 9001, 13485 and 21 CFR820.**- **Strong management and communication skills.**- _**Skills to make presentations to top management.**_- **CERTIFICATES, LICENSES, REGISTRATIONS**:_- _**Certification in ISO 9001 & 13485 desirable.**_- **ATTITUDE, SKILLS AND TEAMWORK**:_- _**The incumbent is required to demonstrate a positive attitude on a consistent basis when working with others
