Onsite Quality Engineer - Medical Devices (Bilingual EN/ES)

Vapotherm; Tijuana; On-site; MXN 420,000 - 640,000; Full time

Job summary

Vapotherm in Tijuana is seeking a hands-on Quality Engineer to support manufacturing operations, investigate quality issues, and drive improvements on the production floor. You will partner with Production, Manufacturing Engineering, Operations, Supply Chain, and Quality teams to ensure compliance with Vapotherm's Quality Management System.

The role requires bilingual English and Spanish (B2) and onsite work at Vapotherm's Tijuana facility.

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum of 3 years in the medical device industry or ISO-regulated manufacturing.
• Experience supporting manufacturing operations and resolving production quality issues.
• Knowledge of FDA QSR, ISO 13485, and ISO 14971.
• Strong root-cause analysis and problem-solving skills.

Responsibilities

• Support manufacturing operations and resolve quality issues on the production floor.
• Lead root cause investigations and CAPA activities.
• Collaborate with cross-functional teams to develop, improve, and maintain processes and documentation.
• Participate in internal and regulatory audits and support MRB activities.
• Monitor quality metrics and drive continuous improvement initiatives.

Skills

Root cause analysis

Process improvement

Quality systems

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Excel

Databases

Word processing

Job description

Vapotherm in Tijuana is seeking a hands-on Quality Engineer to support manufacturing operations, investigate quality issues, and drive improvements on the production floor. You will partner with Production, Manufacturing Engineering, Operations, Supply Chain, and Quality teams to ensure compliance with Vapotherm's Quality Management System.

The role requires bilingual English and Spanish (B2) and onsite work at Vapotherm's Tijuana facility.