Senior Supplier Quality Engineer

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

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.