Senior Supplier Quality Engineer
Outset Medical, Inc.Tijuana, Baja California, Mexico
Posted June 2, 2026
Full Time
About the Company
Outset Medical is a trailblazing medical device company that is revolutionizing the field of dialysis.
Job Description
Join Outset Medical, a trailblazing medical device company, as a Senior Supplier Quality Engineer to maintain and improve the quality of materials and components. Drive continuous improvement initiatives, conduct audits and capability assessments, and analyze supplier performance data to identify trends and areas for improvement.
Requirements
- 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
- Strong verbal and written communication skills in English
- Comprehension of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971
- Effective analytical, technical, and problem-solving skills
- Deep knowledge of sampling plans and statistical techniques
- Lead Auditor certification
Benefits
- Medical device industry experience
- Regulated industry experience
- Communication skills in English
- Knowledge of medical device regulations and standards
