Senior Director Quality Assurance in Chula Vista, CA

$200K - $250K(Ladders Estimates)

Merit Medical Systems Inc   •  

Chula Vista, CA 91909

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 73 days ago

This job is no longer available.

Job Description

JOB DUTIES


Direct all aspects of Quality Assurance Programs for Merit Medical Systems, Inc. in Latin America using prior experience in leading QA organizations for multiple locations in Latin America and using the ability to speak university-level Spanish and English.

Respond to regulatory agency and customer contacts on quality related queries and compliance audits, using prior experience as a Quality Engineer for medical device product manufacturing and in the development of cardiovascular and vascular access devices within Latin and North America.

Develop strategy to meet regulations applicable to the processes managed, products produced, and global markets, using FDA Medical Device Regulations, including 21 CFR 820, 21 CFR 801, and 21 CFR 807 (US); ANVISA RDC 16/2013 Technical Regulation of Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices (Brazil); NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos medicos (Mexico); Medical Devices Directive (93/42/EEC); ISO 13485 Quality System Standard (International) ISO 14971 Risk Management; Canadian Medical Device Regulation (CMDR) (Canada); and PMDA Pharmaceuticals Medical Devices Act & MO #169 Ministerial Ordinance No. 169 (Japan).

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.

As a member of the Senior Leadership Team, 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.

Manage the transition of new products and technologies to Operations groups within Latin American.

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.

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, 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.

Track information about customer complaints in order to provide the Design, Development and Operations teams with product quality information.

Provide direction and effective management to assigned departments within the Quality Assurance team in Latin America, ensuring that each department is resourced, structured, and managed.

Review performance of Latin American Quality Assurance staff in achieving compliance and system improvement objectives using the ability to speak university-level Spanish and English.

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):

  • Demonstrable knowledge of and prior experience with FDA Medical Device Regulations, including 21 CFR 820, 21 CFR 801, and 21 CFR 807 (US); ANVISA RDC 16/2013 Technical Regulation of Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices (Brazil); NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos medicos (Mexico); Medical Devices Directive (93/42/EEC); ISO 13485 Quality System Standard; ISO 14971 Risk Management; Canadian Medical Device Regulation (CMDR) (Canada); and PMDA Pharmaceuticals Medical Devices Act & MO #169 Ministerial Ordinance No. 169 (Japan).

  • Prior experience in leading organizations through external inspections and audits, including FDA, Notified Bodies, Competent Authorities, Regulatory Agencies and Customers.

  • Prior experience as a Quality Engineer in medical device product manufacturing and in the development of cardiovascular and vascular access devices within Latin and North America.

  • Demonstrable knowledge of and prior experience in performing statistical analysis techniques, including hypothesis testing, types of distributions, and confidence intervals.

  • Demonstrable knowledge of and prior experience in ISO and ASTM biomedical testing standards.

  • Ability to speak university-level Spanish and English.

  • Work from remote location available.


Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice.

Valid Through: 2019-9-4