[Hiring] Quality Engineer 1 @Viant

Role Description

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.

Our Quality Engineers 1 provide quality engineering support to the development and production of Class I, II and III (as applicable) Medical Devices. Responsibilities include:

• Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis.
• Support new product development activities.
• Maintain and manage quality compliance and supplier quality management.
• Support finished goods variance investigation and resolution.
• Conduct complaint investigation, process improvement and quality assurance testing methodology.
• Participate in or lead Corrective/Preventive Action initiatives.
• Support internal/external and suppliers audit, vendor qualification and training programs.
• Participate in Quality/Business initiatives including business process improvement activities and documented Quality System re-architecture.

Principal Responsibilities:

• Prepare and update quality documents and any applicable documentation required to sustain the manufacturing process, system or NPI projects, including documentation linked to the Device Master Records and Device History Records.
• Execute reviewing/approval of any documentation created/updated by the Manufacturing Engineering department (or other) required to sustain the manufacturing process or quality systems.
• Support in analysis, review and implementation of new methodologies, processes, tools that contribute to the improvement on the manufacturing process, quality systems or supplier improvements.
• Checks, provides support and executes initiation/investigation for NCs, Complaints, Calibration, SCARs and Environmental Monitoring.
• Provide follow up to actions generated from corrective and preventive plans.
• Perform other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
• Maintain and follow up CAPA and supplier files (Quality Systems and Supplier Engineer only).
• Support in the execution of qualifications (IQs/OQs/PQs/PPQs/TMVs) with an approved protocol; gather data and analysis results for completing the corresponding report.

Qualifications

• Bachelor degree in Engineering or Science (such as Pharmacy, Microbiology, Physics and Chemistry).
• From 0 to 1 year work experience in manufacturing environment.
• Bilingual English/Spanish – Basic English level, reading comprehension and writing.
• Basic knowledge and application of statistical techniques (basic descriptive statistics).
• Basic knowledge in root cause analysis tools.
• Knowledge of Minitab statistical software is a plus.

Requirements

• 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.
• Proactive.
• Discipline.
• Customer oriented.
• Team player.
• Diligent.
• Retentive.
• Good learner.
• Hands-on, collaborative, decisive.
• Must be flexible and adapt to changing environments and priorities.
• Problem Solving: Basic understanding of problem-solving methodology.
• Metrology: Basic knowledge of measurement and error theory and measuring instruments and equipment.

Company Description

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.