Senior Supplier Quality Engineer: Drive Excellence

Outset Medical, Inc.; Tijuana; Presencial; MXN 900.000 - 1.400.000; Jornada completa

Descripción de la vacante

Outset Medical, Inc. is seeking a Senior Supplier Quality Engineer in Baja California, Mexico. The role focuses on maintaining and improving supplier quality of materials and components, driving supplier performance, and ensuring compliance with medical device standards.

You will lead audits, CAPA, and supplier control plans, collaborating with suppliers and internal teams to enhance product quality and process reliability. Strong English communication and Six Sigma expertise are essential.

Formación

• Bachelor’s degree in quality, Mechanical, or Industrial Engineering, or related field.
• Minimum 5+ years of supplier quality or supplier qualification experience.
• Experience in a medical device or regulated industry.
• Strong verbal and written English communication.
• Familiarity with 21 CFR 820, GMP, EN ISO 13485, ISO 14971.
• Ability to read technical data (drawings, GD&T).
• Analytical, technical, and problem-solving abilities with Six Sigma methodology.
• Knowledge of sampling plans and statistical techniques.
• Lead Auditor certification.

Responsabilidades

• Drive continuous improvement initiatives with suppliers and internal teams.
• Conduct supplier audits and capability assessments of facilities, processes, and quality systems.
• Analyze supplier performance data to identify trends and improvement areas.
• Follow up corrective actions and assess root cause analysis tools.
• Support change orders for process improvements and stability studies.
• Analyze failures on non-conforming products.
• Review PPAP, MSA, and supplier control plans.
• Manage qualification changes and supplier/company change control.
• Prepare monthly supplier quality trend analyses (scorecards).
• Lead supplier qualification and maintenance, including audits and new supplier introductions.
• Maintain strong supplier relationships and stakeholder collaboration.

Conocimientos

Analytical skills

Problem solving

Communication

Process improvement

Six Sigma

Root cause analysis

Statistical methods

Quality systems

Educación

BSc in quality/Mechanical/Industrial Eng

Herramientas

Lead Auditor certification

PPAP

Descripción del empleo

Outset Medical, Inc. is seeking a Senior Supplier Quality Engineer in Baja California, Mexico. The role focuses on maintaining and improving supplier quality of materials and components, driving supplier performance, and ensuring compliance with medical device standards.

You will lead audits, CAPA, and supplier control plans, collaborating with suppliers and internal teams to enhance product quality and process reliability. Strong English communication and Six Sigma expertise are essential.