Quality Engineer

Vapotherm; Tijuana; Presencial; MXN 420 000 - 640 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Root cause analysis

Process improvement

Quality systems

Data analysis

Cross-functional collaboration

Formação académica

Bachelor's degree in Engineering

Ferramentas

Excel

Databases

Word processing

Descrição da oferta de emprego

The Quality Engineer is a hands-on role responsible for supporting manufacturing operations and driving quality improvements on the production floor. This position partners closely with Production, Manufacturing Engineering, Operations, Supply Chain, and Quality teams to identify, investigate, and resolve quality issues, improve manufacturing processes, and ensure compliance with Vapotherm's Quality Management System. The Quality Engineer will spend significant time in the manufacturing environment supporting production activities, addressing nonconformances, leading root cause investigations, and implementing corrective and preventive actions. This role serves as a key quality partner to production and technical teams, ensuring product quality, regulatory compliance, and operational excellence. Candidates must be bilingual in English and Spanish with B2-level proficiency in speaking and writing and be able to work onsite at Vapotherm's Tijuana location.

Preferred Qualifications

• Serve as the primary Quality representative supporting daily manufacturing operations and production activities.
• Work directly with production personnel and cross-functional technical teams on the manufacturing floor to identify, troubleshoot, and resolve quality issues.
• Participate in the execution of quality functions in compliance with FDA QSR, ISO 13485, ISO 14971, and other applicable national and international standards.
• Lead investigations of manufacturing nonconformances, defects, and process deviations using root cause analysis methodologies.
• Drive corrective and preventive actions (CAPA) and verify the effectiveness of implemented solutions.
• Support and execute process verifications and validations, including IQ/OQ/PQ activities and associated documentation.
• Collaborate with Production, Manufacturing Engineering, and other cross-functional teams to develop, improve, and maintain manufacturing processes and documentation.
• Support risk management activities, including process FMEA (pFMEA).
• Review, create, and update procedures, work instructions, and quality documentation.
• Participate in Material Review Board (MRB) activities and support disposition of nonconforming materials.
• Monitor quality metrics, analyze trends, and identify opportunities for corrective action and process improvement.
• Assess manufacturing processes and quality performance to identify opportunities for continuous improvement.
• Support supplier quality activities, including audits, validations, and change management.
• Conduct internal audits and support external audits and regulatory inspections.
• Represent Quality on new product introduction, process improvement, and manufacturing projects.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• Minimum of 3 years of experience in the medical device industry or another ISO regulated manufacturing environment.
• Experience supporting manufacturing operations and resolving production quality issues.
• Knowledge of FDA Quality System Regulations (QSR), ISO 13485, and ISO 14971.
• Strong root cause analysis and problem-solving skills utilizing tools such as 5 Why, Fishbone, FMEA, or similar methodologies.
• Knowledge of statistical methods and data analysis techniques.
• Proficient in Microsoft Excel, databases, and word processing software.
• Bilingual in English and Spanish with B2-level proficiency in speaking and writing.
• Ability to work onsite at Vapotherm's Tijuana location.
• Strong verbal and written communication skills.
• High attention to detail, organization, and follow-through.
• Ability to work independently and collaboratively in a fast-paced manufacturing environment.
• Customer/patient-focused approach to quality and continuous improvement.

Preferred Qualifications

Auditor certification (e.g., ISO 13485 Internal Auditor, Lead Auditor, or equivalent) is a plus.

Experience in Lean Manufacturing and Continuous Improvement methodologies, including Kaizen, Standard Work, 5S, Kanban, SMED, Value Stream Mapping (VSM), and Poka-Yoke.

Experience supporting CAPA, nonconformance management, and process validation activities.

Experience participating in supplier quality initiatives and audit programs.

Knowledge of medical device manufacturing processes and regulatory requirements.