Quality Engineer II - CR

About the role

Terumo Neuro is hiring a Quality Engineer II in Alajuela, Costa Rica, to support the development and manufacturing of existing and new medical devices. The engineer works with Manufacturing and R&D to resolve product quality issues, including field complaints, and supports manufacturing process changes, product design improvements and the introduction of new products.

Key responsibilities

• Review process changes with manufacturing engineers, resolve quality issues and assess related risks.
• Work with suppliers to maintain high quality of incoming materials and take part in supplier quality audits when required.
• Support new product implementation with R&D by reviewing quality and testing plans, and help develop FMEAs.
• Develop test protocols and reports (design verification, design validation, process qualification and process validation) and check their execution.
• Maintain quality systems such as CAPA, non-conformance, supplier quality, equipment calibration, internal auditing and quality metrics data analysis, as assigned.
• Comply with laws and regulations, follow Quality Management System processes and act with ethics and integrity.

Required profile

• Bachelor's degree in engineering or a related field.
• At least 3 years of related medical device manufacturing experience.
• Intermediate computer skills and knowledge of MS Office (Word, Excel, PowerPoint, Teams, Outlook).
• English level B1 or above (based on the Belt Certification Process).
• Ability to read and interpret PFMEA risk assessments, and at least 1 year of root cause analysis experience (Fishbone); certification not mandatory.
• Ability to read, interpret and execute validation processes (TMs / VQPs & VQRs) and production and process controls.
• At least 1 year of hands-on experience handling and evaluating nonconforming products.
• Strong written and verbal communication skills.

Required skills

• Desired: basic knowledge of ISO 13485 and familiarity with medical device quality systems and regulations.
• Desired: basic knowledge of complaint handling, nonconforming product handling and risk management (e.g. ISO 14971).
• Desired: proficiency with statistical software such as Minitab, Stratigraphic and Design of Experiments (DOE).