This is a permanent full-time position to work in our Heredia site located in Zona Franca Metropolitana. Remote work might be part of, based on business needs.

Our Quality Engineers 3 provides quality engineering support to the development and production of Class I, II and III (as applicable) Medical Devices. 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, 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, documented Quality System re-architecture and other cross-functional projects.

Principal Responsibilities:

• Coordinate the development of new processes inspections by interfacing with personnel from product design and development, quality assurance, production, manufacturing, process/assembly technology and external vendors / customers.
• Participate in the preparation of quality metrics required for Management Review, Operations Review or Quality Metrics meetings.
• Review drawings, analyze tooling, and recommend improvements leading to increase productivity, quality, and safety for new or existing manufacturing processes.
• Coordinate and carry out qualification and validation activities for new products, processes, changes and transfers as per FDA regulations (IQ, TMV, OQ, PQ and Quality Plans). Prepare respective validation protocols and reports for moderate and high complexity qualifications or participate in the approval of them.
• Executes 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.
• Responsible for the elaboration of risk management documentation such as Risk Management Plan / Report and Process FMEAs.
• Become supervisor of Quality Inspectors / Technicians / Specialists and be responsible for the tasks assignation / coordination of this personnel in charge.
• Train Quality Assurance Inspectors and manufacturing personnel in understanding of procedures, specifications, environmental controls, etc.
• Act as a quality system internal auditor. Participate in communications with the customers including weekly sustaining report out meetings, QBRs, projects meetings, other.

Knowledge / Education

• Minimum education required to perform duties: Bachelor degree in Engineering or Science (such as Pharmacy, Microbiology, Physics and Chemistry).
• Bilingual English/Spanish – Advanced English level (written and spoken).
• Knowledge of applicable regulations for the medical device industry (FDA, ISO, other.)
• Knowledge and application of risk management (PFMEA’s).
• Knowledge of process validation.
• Knowledge in root cause analysis tools.
• Knowledge and application of statistical techniques (Sampling Plans, Gage R&R’s, Hypothesis Test, Statistical Process Control {SPC}, Process Capability Studies, Design of Experiments {DOE}).
• Knowledge of Minitab statistical software.
• Knowledge of Six Sigma Methodology and Lean Manufacturing.

Job Experience

• At least 2 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

• Effective planning and time management
• Customer oriented
• Results oriented
• Analytical
• Innovative
• Self-starter willing to take calculated risks.
• Demonstrated leadership and motivational skills.
• Problem Solving: Must be able to identify cause and effect relationships, analyze data and complete root cause analysis.
• Metrology: Capable of developing measuring procedures and test methods, selecting test equipment, measuring instruments and validating test methods.
• Decision making: Capable of making medium risk decisions for specific projects and situations.