Senior Supplier Quality Engineer

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

The Senior Supplier Quality Engineer (SQE) plays a critical role in maintaining and continuously improving the quality of materials and components procured by the business. This position oversees supplier performance, provides regular reports to management to ensure transparency and accountability, and contributes to the refinement of supplier control plans to drive ongoing quality improvement. By collaborating closely with suppliers, the Senior SQE develops and implements strategies to enhance product quality, process reliability, and overall supplier capability. Success in this role requires strong analytical and problem-solving skills, the ability to manage multiple priorities effectively, and a proactive approach to ensuring consistent compliance with company and regulatory standards.

Essential Job Functions and Responsibilities

• Driving continuous improvement initiatives with suppliers and internal teams.
• Conduct comprehensive audits and capability assessments of supplier facilities, processes, and quality systems.
• Analyzing supplier performance data to identify trends and areas for improvement.
• Follow up corrective actions, ensuring the implementation of corrective actions in response to quality issues, while also assessing the adequacy of root cause analysis tools employed to address reported issues.
• Support or execute change orders for process improvements and determine when process stability and capability studies should be performed on existing suppliers.
• Analyzes and conducts failure analysis on non-conforming products.
• Review and participate in the component qualifications (PPAP), MSA, and supplier control plans.
• Manage qualifications of changes, oversee the qualification process for changes initiated by suppliers and the company, and coordinate associated change control activities to ensure seamless integration and compliance with quality standards.
• Develops and prepares monthly suppliers quality trend analysis (Scorecards).
• Lead the supplier qualification and maintenance process, including audits, new supplier introduction.
• Good communication and interpersonal skills, such as supplier relationships, internal collaboration, stakeholder management, problem solving, influencing, negotiation, and customer satisfaction.

Required Qualifications

• Bachelor’s degree in quality, Mechanical, or Industrial Engineering, or related field.
• Minimum of 5+ years of supplier quality or working with supplier qualification projects.
• Experience in a medical device or other regulated industry is required.
• Strong verbal and written communication skills in English are required.
• Comprehension of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971.
• Able to read and understand technical data (drawings, GD&T, etc.).
• Effective analytical, technical, and problem-solving skills. Applies rigorous methodology to complex problems, including Six Sigma methodology.
• Deep knowledge of sampling plans and statistical techniques.
• Lead Auditor certification.

Desired Qualifications

• Certification in Quality elements such as Quality Engineering or Lean Six Sigma.
• Flexibility to travel domestically and internationally for supplier visits and audits.