Senior Supplier Quality Engineer

Responsibilities

• Drive continuous improvement initiatives with suppliers and internal teams
• Conduct comprehensive audits and capability assessments of supplier facilities and quality systems
• Analyze supplier performance data to identify trends and areas for improvement
• Follow up on corrective actions and assess root cause analysis adequacy
• Support or execute change orders for process improvements
• Perform failure analysis on non-conforming products
• Review component qualifications (PPAP), MSA, and supplier control plans
• Manage supplier change qualifications and coordinate change control activities
• Develop and prepare monthly supplier quality trend analysis scorecards
• Lead supplier qualification and maintenance processes including new supplier introduction

Requirements

• Bachelor’s degree in Quality, Mechanical, or Industrial Engineering
• Minimum 5+ years of supplier quality or supplier qualification experience
• Experience in medical device or other regulated industries
• Proficiency in English (verbal and written)
• Knowledge of 21 CFR 820, GMP, EN ISO 13485, and ISO 14971
• Ability to read technical data, drawings, and GD&T
• Strong analytical and problem-solving skills using Six Sigma methodology
• Deep knowledge of sampling plans and statistical techniques
• Lead Auditor certification

Preferred Qualifications

• Certification in Quality Engineering or Lean Six Sigma
• Experience working in an international environment
• Flexibility to travel domestically and internationally for supplier visits and audits

About the Company

Outset Medical is a trailblazing medical device company revolutionizing the field of dialysis. Through the Tablo® Hemodialysis System, Outset is creating first-of-its-kind technology to reduce the cost and complexity of dialysis care for patients and providers.