Gerente de Aseguranza de Calidad

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.**_- Ability to work in matrix management and able to work collaboratively and cross- functionally as well as across the organization.- _**Broad understanding of manufacturing processes.**_- Strong organizational and communication skills.- Ability to conduct training and present material to a wide range of audiences.- Problem solving ability through technical knowledge.- Must be able to influence others at all levels of the organization.- Must be able to work on personal initiative, have the flexibility to manage change, be able to multi-task and prioritize workload.- _**Must be confident in their ability to make decisions balancing business requirements with quality requirements and the associated risks**_- Must possess excellent computer skills, i.e.: Microsoft Office including Excel, Word and Power Point.- JD Edwards or an ERP system experience is a plus.- _**ETQ knowledge required.**_- _**The incumbent must demonstrate and promote teamwork on a consistent basis within the assigned department as well as across functional lines of operations effectively maintaining close communication with all required employees.**_- **LANGUAGE SKILLS**:_- _**The position requires the ability to effectively communicate to all levels of organization and be fluent in speaking and writing in both English and Spanish.**_- **ARITMETICAL OPERATION SKILLS**:_- _**The position requires the ability to add, subtract, multiply and divide in all units of measure, using whole numbers and common fractions as well as decimals and must have the ability to calculate radius and percentage, as well as define bar graphs and know how to interpret your information.**_- **PROBLEM SOLVING ABILITY**:_- **PHYSICAL DEMANDS**:_- _**The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to communi