Senior Supplier Quality Engineer: Drive Supplier Excellence

Outset Medical, Inc.; Tijuana; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Outset Medical, Inc. is seeking a Senior Supplier Quality Engineer to lead supplier quality programs and audits for medical device components. The role emphasizes improving supplier quality, coordinating PPAP/MSA, and driving reliability across supplier facilities.

The candidate should bring 5+ years of supplier quality experience in regulated environments, strong problem-solving skills, and expertise in Six Sigma and measurement systems analysis to ensure compliance and continuous improvement.

Formación

• Bachelor’s degree in quality, mechanical, or industrial engineering.
• 5+ years in supplier quality or supplier qualification projects.
• Experience in medical device or regulated industry.
• Strong English communication skills.
• Knowledge of 21 CFR 820, GMP, EN ISO 13485, ISO 14971.
• Lead Auditor certification.

Responsabilidades

• Drive continuous improvement with suppliers and internal teams.
• Audit supplier facilities, processes, and quality systems.
• Analyze supplier data to identify trends and areas for improvement.
• Follow up corrective actions and assess root cause analysis tools.
• Support change orders and process stability/capability studies.
• Conduct failure analysis on non-conforming products.
• Review PPAP, MSA, and supplier control plans.
• Lead supplier qualification, audits, and new supplier introductions.
• Develop monthly supplier quality trend analyses (scorecards).
• Collaborate with stakeholders to ensure quality standards.

Conocimientos

Six Sigma

Lead Auditor

Statistics

Root Cause Analysis

Educación

Bachelors in quality/Mechanical/Industrial Eng

Descripción del empleo

Outset Medical, Inc. is seeking a Senior Supplier Quality Engineer to lead supplier quality programs and audits for medical device components. The role emphasizes improving supplier quality, coordinating PPAP/MSA, and driving reliability across supplier facilities.

The candidate should bring 5+ years of supplier quality experience in regulated environments, strong problem-solving skills, and expertise in Six Sigma and measurement systems analysis to ensure compliance and continuous improvement.