Senior Director Quality Assurance, Latin America

Company: Acuren Group Inc
Location: Chula Vista
Posted on: February 22, 2021

Job Description:

Senior Director Quality Assurance, Latin America #500-22415 Working Hours (8 am to 5 pm) M-F Shift 1st Area of Interest Z-Testing Job Description Employer: Merit Medical Systems, Inc. Location of Employment: 1711 Quiet Trail Drive, Chula Vista, California 91915 Job Title : Senior Director Quality Assurance, Latin America Job Duties:

• Direct all aspects of Quality Assurance Programs for Merit Medical Systems, Inc. in Latin America utilizing knowledge of and prior experience in startup of manufacturing & distribution operations in Latin America;
• Respond to regulatory agency and customer contacts on quality related queries and compliance audits, using prior experience as a Quality Manager for medical device product manufacturing and in the development of cardiovascular and vascular access devices within Latin and North America;
• Comply with company and regulatory standards and identify opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase product value, and increase customer satisfaction using knowledge of and prior experience in statistical analysis techniques including hypothesis testing, types of distributions, and confidence intervals ;
• Manage and develop processes to meet the goals the Company, including Best in Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development ;
• Interpret Quality System regulations applicable to Latin America Operations and communicate findings to Quality and Operational Leadership within the region ;
• Coordinate with Research and Development (Product & Technology) team to ensure safe and effective product design, customer requirements, and compliance with design control requirements, using ISO and ASTM biomedical testing standards. and Farmacopea de los Estados Unidos Mexicanos, Suplemento de Dispositivos Medicos biomedical testing standards ;
• Manage the transition of new products and technologies to Operations groups within Latin America using experience in manufacturing processes implementation in Latin American Countries ;
• Provide technical support for the manufacturing of existing products and growth and development transfer of new products and technologies ;
• Prepare and review written procedures and documentation for Quality System Processes, and Testing and Manufacturing processes utilizing experience certifying clean rooms to International standards as well to specific requirements defined in Mexican regulation NOM-241-SSA1-2012 ;
• Conduct an independent review of all verification and validation activities ;
• Oversee responses to agency reviews and audits using prior experience in leading organizations through external inspections and audits including FDA, COFEPRIS, Notified Bodies, Competent Authorities, Regulatory Agencies and Customers ;
• Provide recommendations and decisions regarding the disposition of non-conforming products, including determining when Regulatory/Clinical approval is required, stopping production lines and/or product shipments if problems with quality arise, and initiating preventive and corrective actions to ensure non-recurrence ;
• Coordinate with Commercial Teams to establish a Distribution Channels within the region utilizing knowledge of an experience in the implementation of Quality Systems for Distribution centers in Latin America countries including Suplemento para Establecimientos dedicado a la venta y dem--s insumos para la salud en Mexico ;
• Track information about customer complaints in order to provide the Design, Development and Operations teams with product quality information . Degree Requirement : Bachelor's Degree in Industrial Engineering, Quality Engineering, Materials Engineering, Biomedical Engineering, or closely related field. Foreign degree accepted. Experience Required : Ten years' experience as a Quality Assurance Manager, Regulatory Affairs Manager, Engineering Manager, or closely related field. Skill set Requirements (Special Requirements):
  • Ten years' experience as a Quality Assurance Manager, Regulatory Affairs Manager, Engineering Manager, or closely related field, must include 4 years based in Latin America performing direct regional support;
  • Demonstrable knowledge of and prior experience in startup of manufacturing & distribution operations in Latin America;
  • Ability to speak and write university-level Spanish and English;
  • Demonstrable knowledge of and prior experience in performing statistical analysis techniques, including hypothesis testing, types of distributions, and confidence intervals;
  • Prior experience as a Quality Manager in medical device product manufacturing and in the development of cardiovascular and vascular access devices within Latin and North America;
  • Demonstrable experience in manufacturing processes implementation in Latin American Countries;
  • Demonstrable experience certifying clean rooms to International standards as well to specific requirements defined in Mexican regulation NOM-241-SSA1-2012;
  • Prior experience in leading organizations through external inspections and audits, including FDA, COFEPRIS, Notified Bodies, Competent Authorities, Regulatory Agencies and Customers Travel Requirements : Travel to Merit Medical Systems, Inc. head office in South Jordan, Utah at a minimum 1 time per month for periods of up to 5 days per trip. Travel to Merit Medical Systems, Inc. facility in Tijuana, Mexico 2 times per month for periods up to 5 days per trip. Travel to Merit Medical Systems, Inc. facilities in S--o Paulo, Brazil and Joinville, Brazil at a minimum 2 times per year, for up to 5 days per trip. Other travel to internal and external suppliers on as needed basis. Work Hours: 8:00 a.m. -- 5:00 p.m., Monday -- Friday. To Apply: Please submit an application and upload a resume on our website https://www.merit.com/careers/. Only qualified applicants need apply. Do not apply if you are an H-1 or F-1 visa holder, or if you otherwise require employer sponsorship to obtain U.S. employment authorization. Do not apply if you are not eligible to be employed in the U.S.

Keywords: Acuren Group Inc, Chula Vista , Senior Director Quality Assurance, Latin America, Executive , Chula Vista, California