Sr Quality System Engineer

This is a full-time position to work Monday to Friday from 8am to 5pm in our Heredia site located in Zona, Franca Metropolitana. Remote work might be allowed based on business needs. Main Purpose of Job: Provide Quality Systems Engineering support for the development and production of Class I, II and III (as applicable) Medical Devices. Represent Quality in production process efforts, quality planning, Risk Analysis, supporting new product development activities and maintaining / management of quality compliance. Support finished goods variance investigation and resolution, process improvement, participate in or lead Corrective/Preventive Action initiatives. Support internal / external audits and training programs. Participate in Quality/ Business initiatives including business process improvement activities, documented Quality System re-architecture and other cross-functional projects. Main Job Duties/Responsibilities • Support in analysis, review and implementation of new methodologies, processes, tools that contribute to the improvement of the manufacturing process or the quality system. • Provide follow up to actions generated from corrective and preventive plans. Maintain and follow up CAPA files. • Lead all the readiness activities required to receive Internal / External / Customer Quality System Audits. • Create and administrate internal audit schedules. • Support the execution of investigations for audit non-conformances, complaints and Corrective and Preventive Actions (CAPA) to correct a problem presented in the quality system or the manufacturing process. • Act as a quality system internal auditor. • Responsible for the preparation of quality metrics required for Management Review, Operations Review or Quality Metrics meetings. • Manage and lead staff (technicians / specialists / clerks) to obtain company goals, including defining and communicating expectations and assignments, monitoring results, coaching, motivating and following up to achieve goals. • Coordinate projects and act as a leader for all assigned project activities within the quality department. Knowledge / Education • Minimum education required to perform duties: Bachelor’s degree in engineering or science (such as Pharmacy, Microbiology, Physics and Chemistry). • Bilingual English/Spanish – Advanced English level (written and spoken), technical writing and capable of leading presentations. • Advance level of knowledge of applicable regulations for the medical device industry (FDA, ISO, etc.) • Knowledge in root cause analysis tools • Certified Internal Quality Auditor or Lead Auditor is a plus. • Certified Quality Engineer or Black Belt is a plus. Job Experience • At least 4 years' work experience in manufacturing environment. • Project Management experience. • Experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry (i.e. food, aerospace, etc.) is a plus. Skills / Competencies Good interpersonal skills and the ability to communicate orally and in writing. Self-motivated. Organized and able to manage multiple tasks and priorities. Must be able to read and understand specifications. Proficient in the interpretation of technical drawings. Must be able to work and effectively communicate with others. Highest ethical standards and professional integrity. Able to work independently. Teamwork oriented. Decision making: Must be able to quickly and independently make decisions. All skills and competencies listed for categories 1, 2 and 3. Proficiency in at least one manufacturing technical field or any quality subsystem (i.e. process/software validation, CAPA system, statistical techniques, risk management, other.) acquired through either formal training and/or work experience. Problem Solving: Must be able to formulate and implement mitigations or corrective actions for identified root causes. Decision making: Capable of making higher risk decisions within specific value streams. Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.