Supplier Quality Engineer II (CR)

About the role

Terumo Neuro is hiring a Supplier Quality Engineer II (SQE II) in Alajuela, Costa Rica. The SQE II delivers the full Supplier Quality Assurance function, working with suppliers to build best practices focused on defect prevention, reducing variation and waste, and continuously improving compliance with customer requirements. The role also manages customer-specific requirements and offers technical support to suppliers.

Key responsibilities

• Analyze inspection data of finished products, in-process materials and raw materials, identify trends and recommend corrective actions.
• Carry out problem-solving and root cause analysis with suppliers and customers to stop defects recurring.
• Use process improvement tools to drive product and process quality, and monitor supplier quality levels.
• Work with strategic suppliers to meet quality goals, run supplier re-evaluations and maintain the approved supplier list.
• Initiate actions at the RI lab or manufacturing lines to prevent non-conformities, and perform supplier quality audits.
• Develop projects to improve RI and release capabilities, and run test method, software and equipment validations for RI and release inspections.

Required profile

• Bachelor's degree in a related field or equivalent.
• At least two years of related experience.
• Strong written and verbal communication skills; 80% English proficiency, written and spoken.
• Preferred: medical device industry experience.

Required skills

• Root cause analysis and corrective/preventive action methods.
• Quality tools such as 6-sigma, 8-D, CAPA, FMEA and 5 Whys.
• Desired: knowledge of global medical device regulations and standards such as ISO 9001, ISO 13485, QSR and MDD, and reading of engineering drawings.