Quality Engineer 2 - Medical Devices

About the role

Viant, a global provider of medical device design and manufacturing services, is hiring a full-time Quality Engineer 2 for its Heredia site in Zona Franca Metropolitana. The engineer supports the development and production of Class I, II and III medical devices, covering quality planning, process validations, FMEA and risk analysis, new product development, supplier quality and quality compliance. Work is Monday to Friday, 8:00am to 5:00pm, with possible remote work depending on business needs.

Key responsibilities

• Prepare and update quality documents, including those linked to Device Master Records and Device History Records, and review approvals of manufacturing and quality documentation.
• Support analysis and implementation of new methodologies, processes and tools that improve manufacturing, quality systems or supplier performance.
• Check, investigate and follow up on NCs, complaints, calibration, SCARs and environmental monitoring, and follow up on corrective and preventive action plans.
• Maintain CAPA and supplier files (Quality Systems and Supplier Engineer only).
• Support qualification studies (IQ/OQ/PQ/PPQ/TMV) with approved protocols, prepare validation master plans and closure reports, and review validation protocols and reports.
• Ensure laboratory equipment complies with analysis and testing needs, and take part in readiness for internal, external, customer and supplier audits.
• Collaborate on risk management documentation such as risk plans, reports and PFMEAs, and on customer technical drawings, QA specs, control plans and work instructions.
• Communicate with customers on projects, product transfers, weekly sustaining reports and quarterly business reviews, and introduce new hires (Quality Process and Quality Systems Engineer only).
• Create quarterly supplier evaluations and scorecards, and control approved suppliers through document change control (Supplier Quality Engineer only).

Required profile

• Bachelor's degree in Engineering or Science (e.g., Pharmacy, Microbiology, Physics, Chemistry).
• At least 1 year of work experience in a manufacturing environment.
• Bilingual English/Spanish at intermediate level; reading, listening, writing and speaking.
• Experience in medical device manufacturing, pharmaceuticals or another highly regulated industry is a plus.

Required skills

• Basic knowledge of statistical techniques (sampling plans, Gage R&R, hypothesis tests, process capability) and risk management (PFMEA).
• Basic knowledge of FDA, ISO and other medical device regulations, root cause analysis and process validation.
• Knowledge of Six Sigma and Lean Manufacturing, and of Minitab, is a plus.
• Ability to read and interpret technical drawings and specifications.